The present invention relates to a poly herbal oil formulation for menstrual pain. More
particularly, the present invention relates to a polyherbal topical menstrual cramp relief oil
formulation and process for preparation thereof. The present invention helps in relaxation of the muscles during menstruation and for increasing the blood circulation to uterine wall and comfort during menstruation. The present invention is helpful in relief from cramps or pain
associated during menstruation mainly for Primary dysmenorrhea.
BACKGROUND OF THE INVENTION:
Menstruation occurs when the uterus sheds its lining once a month. Some pain, cramping,
and discomfort during menstrual periods is normal. But the excessive pain that causes
females to miss work or school is unbearable pain. Painful menstruation is also called
dysmenorrhea. There are two types of dysmenorrhea: primary and secondary. Primary
dysmenorrhea occurs in people who experience pain before and during menstruation. If
you’ve had normal periods that become painful later in life, it may be secondary
dysmenorrhea. A condition affecting the uterus or other pelvic organs, such
as endometriosis or uterine fibroids, can cause this.
Causes of Menstrual Pain
Prostaglandins are chemicals the body makes that cause many of the symptoms associated
with menstrual discomfort. The tissue that lines the uterus makes these chemicals.
Prostaglandins stimulate the uterine muscles to contract. People who have high levels of
prostaglandin may have more intense contractions of their uterus and more pain.
Prostaglandins may also be responsible for vomiting, diarrhea, and headaches that
accompany painful periods. Other menstrual-type cramps (secondary dysmenorrhea) can
be caused by conditions of the reproductive tract, such as the following:
 Endometriosis -- tissue similar to uterine tissue grows outside the uterus.
 Fibroids and adenomyosis -- noncancerous (benign) growths in the uterus
 Infections in the reproductive organs (PID);
2
 Abnormal pregnancy, such as an ectopic pregnancy (pregnancy in the tubes,
outside the uterus)
 IUD (intrauterine device) used for birth control
 Ovarian cyst
5  Narrow cervix
If you have had menstrual pain ever since your periods started, the condition is called
primary dysmenorrhea. If a physical condition such as pelvic inflammatory
disease or endometriosis has developed and is causing the pain, this is called secondary
dysmenorrhea. Once the medical condition is treated, the menstrual pain usually goes away.
10 The person is more likely to have menstrual cramps if: The person had her first period at
an early age (younger than 11); Her menstrual periods are heavy; She is
overweight or obese; She smokes cigarettes or drink alcohol.
There are several Symptoms of Menstrual Pain like Lower back pain; Leg pain radiating
down the legs; Nausea; Vomiting; Diarrhea; Headaches; Irritability; Weakness and
Fainting spells (in extreme cases). Menstrual pain or cramps are pains in female’s
lower abdomen that happen when menstrual period begins (or just before). This pain may
continue for 2 to 3 days. Cramps may be throbbing or aching, and they can be dull or sharp.
Symptoms can range from a mild discomfort to serious pain that interferes with female’s normal
activities. Menstrual cramps are the leading cause of absenteeism in women younger than 30.
Although over half of people who have menstrual periods feel some discomfort, 10% are
temporarily disabled by symptoms.
A hormone called prostaglandin triggers muscle contractions in uterus can cause pain and
inflammation. The level of prostaglandin rises right before menstruation begins. Painful
menstrual periods can also be the result of an underlying medical condition, such as:
 Premenstrual syndrome (PMS). PMS is a common condition that’s caused by
hormonal changes in the body occurring 1 to 2 weeks before menstruation begins.
Symptoms typically go away after bleeding begins.
3
 Endometriosis. This is a painful medical condition in which cells from the lining of
the uterus grow in other parts of the body, usually on the fallopian tubes, ovaries, or
tissue lining the pelvis.
 Fibroids in the uterus. Fibroids are noncancerous tumors that can put pressure on
the uterus or cause abnormal menstruation and pain, though they often don’t cause
symptoms.
 Pelvic inflammatory disease (PID). PID is an infection of the uterus, fallopian tubes,
or ovaries often caused by sexually transmitted bacteria (Chlamydia) that cause
inflammation of the reproductive organs and pain.
 Adenomyosis. This is a rare condition in which the uterine lining grows into the
muscular wall of the uterus, causing inflammation, pressure, and pain. It can also
cause longer or heavier periods.
 Cervical stenosis. Cervical stenosis is a rare condition in which the cervix is so small
or narrow that it slows menstrual flow, causing an increase of pressure inside the
uterus that causes pain.
One of the prior art means discloses a Sanfe Feminine Cramp Relief Roll On.
A revolutionary product designed for severe menstrual cramps and painful periods. The
powerful formulation of blended essential oils not only instantly relieve you from the
throbbing pain in your lower abdomen and agonizing cramps, but also soothe bloating.
Sanfe roll-on is your go-to period buddy for all types of cramps – leg cramps, muscle pain,
lower back pain, and pelvis pain. The 100% natural and stain-free formula is highly effected
for instant action. Now no more twisting and turning in bed with period cramps; no more
saying no to important meetings gatherings, and celebrations with - because with Sanfe roll
on, you are ready to take on the world.
The following are the ingredients of the Sanfe Feminine Cramp Relief Roll On.

Eucalyptus Oil
Eucalyptus is known for its healing and medicinal properties. It works in reducing menstrual
cramps and inflammation.
Satva Pudina
Mint leaves or Pudina has anti-spasmodic properties, which works as a natural pain reliever.
It helps in soothing sore muscles.
Wintergreen Oil
Wintergreen Oil has a soothing fragrance. It's a great cure for achy muscles and bloating.
Soothing Fragrance
Aromatherapy helps in easing the period pain. It gives you a calming and relaxing effect by
easily absorbing into your skin.
Another one prior art means is disclosed in Meelanto Women Feminine Cramp Period
Pain Relief Roll On
a. Enriched with the healing benefits of Menthol and anti-inflammatory effect of
Eucalyptus oil to helps relieve the pain
b. Soothing fragrance mixed with natural ingredients absorbs easily and ensures
hormonal balance
c. Provides Instant relief on Abdomen, lower back and legs
d. Cramp relief roll on - enriched with the healing benefits of menthol and anti20 inflammatory effect of eucalyptus oil to helps relieve the pain. Provides instant relief
on abdomen, lower back, and legs
e. Cramp relief roll on - soothing fragrance mixed with natural ingredients absorbs
easily and ensures hormonal balance
The prior art means used for menstrual pain relief causes adverse side effects. Until now
there has been no single method is developed to effectively combat these symptoms. Thus
far, no conventional form of intervention has been proven to show significant success in
ameliorating menstrual pain and primary dysmenorrhea.
Thus, there is a need to provide a polyherbal topical menstrual cramp relief oil formulation
and process for preparation thereof for primary dysmenorrhea. The present invention is with
an improved therapeutic efficacy without any adverse toxic effects associated with
conventional modes of treatment. The present invention provides a polyherbal topical
menstrual cramp relief oil formulation which reduces anxiety and breast tenderness and
helps in easing irritability and helps to relieve mood swings. The present invention is cost
effective and minimum amount of oil is required for application on painful area and the oil
formulation is absorbed uniformly and faster on the body through Roll on device. The present
invention has uniform spillage of oil from roll on device on the painful area of human body.
OBJECTS OF THE INVENTION:
The main object of the present invention is to provide a polyherbal topical Menstrual cramp
relief oil formulation and process for preparation thereof for primary dysmenorrhea which
reduces anxiety and breast tenderness and helps in easing irritability and helps to relieve
mood swings.
Another object of the present invention is to provide a cost effective solution which provide
an improved therapeutic efficacy without any adverse toxic effects associated with
conventional modes of treatment.
Yet another object of the present invention is to provide a polyherbal topical menstrual cramp
relief oil formulation to help in relieving primary dysmenorrhea associated symptoms like
anxiety and lack of energy.
Summary of the Invention:
Accordingly, a Polyherbal topical menstrual cramp relief oil formulation and process for
preparation thereof is disclosed. A polyherbal topical Menstrual cramp relief oil formulation
with active ingredients and excipients (binding agents) comprising of; 1000mg of Eucalyptus
oil; 50mg of Clove oil; 50mg of Menthol; 50 mg of Camphor; 150mg of Boswelia serrata;
antioxidant such as 1 mg of Butylated Hydroxy Toluene; 500 mg of Iso Propyl Myristate;
0.1250mg of Pain Relief/FFF-88194 (ELVIS); and q. s to 5 ml of Light liquid paraffin. The
present invention relaxes muscles during menstruation and increases the blood circulation
6
to uterine wall and comfort during menstruation. The aromatic blend lightens the mood and
also gives relaxation. The roll on oil is applied on low back area, low abdominal area and
thigh area 3 times.
DESCRIPTION OF THE DRAWINGS:
Fig 1 depicts the graph for baseline in quality of life-health status.
Fig 2 shows total means score ACOG – PMS questionnaire.
Fig 3 depicts menstrual pain intensity-VAS score.
Fig 4 shows graph showing change from baseline upto day 5 in ESR level.
Fig 5 shows graph showing change from baseline upto day 5 in Hs CRP level.
Fig 6 depicts graph showing change from baseline upto day 5 in PGF2α level.
Fig 7 shows graph showing change from baseline upto day 5 in serum fibrinogen level.
DETAILED DESCRIPTION OF THE INVENTION WITH REFERENCE TO DRAWINGS:
The invention will now be described in detail in connection with certain preferred and optional
cramps or pain associated during menstruation. The present invention relaxes muscles
during menstruation and increases the blood circulation to uterine wall and comfort during
menstruation. The aromatic blend lightens the mood and also gives relaxation. The roll on
oil is applied on low back area, low abdominal area and thigh area.
In one embodiment of the present invention, the Polyherbal topical Menstrual cramp relief
oil formulation comprising of Eucalyptus oil; Clove oil or Lavang oil; Menthol; Camphor;
7
Boswelia serrata; Iso Propyl Myristate; Butylated Hydroxy Toluene; Pain Relief/FFF-88194
(ELVIS) and Light liquid paraffin.
The roll on oil has to be applied on the pain affected lower abdomen, thigh and lower back
3 times daily, for a period of 5 days during the menstrual cycle. The present invention
reduces the cramps caused during menstruation. The present invention helps to reduce pain
and irritation.
In a preferred embodiment of the present invention, a Polyherbal topical Menstrual cramp
relief oil formulation (for 5 g) comprising of active ingredients like 1000mg of Eucalyptus oil;
50mg of Clove oil; 50mg of Menthol; 50 mg of Camphor; 150mg of Boswelia serrata and
excipients selected from the group of Iso Propyl Myristate; Butylated Hydroxy Toluene; Pain
Relief/FFF-88194 (ELVIS) and q. s to 5 ml of Light liquid paraffin.
Eucalyptus oil:
Eucalyptus oil is the generic name for distilled oil from the leaf of Eucalyptus, a genus of the
plant family Myrtaceae native to Australia and cultivated worldwide. Eucalyptus oil has a history
of wide application, as a flavouring, fragrance and industrial uses. The leaves of
selected Eucalyptus species are steam distilled to extract eucalyptus oil. The main chemical
components of eucalyptus oil, eucalyptol and alpha-terpineol give the oil a soothing, cooling vapour.
Clove oil or Lavang oil:
Clove bud oil is used to help improve circulation and to soothe muscle aches and pains, cloves
are the active ingredient that helps the blood flow through the area and help reduce the pain.
Clove oil is ideal for reducing the pain and discomfort typically associated with tension
headaches. There are several ways to utilize this leaf. If you have natural clove leaves, cloves
are a natural way to help soothe the pain. Clove oil contains a chemical called eugenol that may
help to decrease pain.
8
Bud oil is derived from the flower-buds of S. aromaticum. It consists of 60–90% eugenol, acetyl
eugenol, caryophyllene and other minor constituents.
Leaf oil is derived from the leaves of S. aromaticum. It consists of 70–82% eugenol, and
some amounts of beta Caryophyllene and alpha Humulene. Stem oil is derived from the twigs of S. aromaticum. It consists of 85–92% eugenol, with
other minor constituents. Stem oil is closer in olfactive and flavor profile to Bud oil.
Distilled clove oil from buds contains mixed phytochemicals, including as main
constituents phenylpropanoids (primarily eugenol), carvacrol, thymol, and cinnamaldehyde,
with smaller quantities of polyphenols, carbohydrates, lipids, oleanolic acid, and rhamnetin.
It contains eugenol a phenyl propene derivative which causes hyper-polarization showing
its anesthetic property in smooth muscles.
Menthol:
Menthol is an organic compound made synthetically or obtained from peppermint or mint oils
with flavoring and local anesthetic properties. When added to pharmaceuticals and foods,
menthol functions as a fortifier for peppermint flavors. It also has a counterirritant effect on skin
and mucous membranes, thereby producing a local analgesic or anesthetic effect.
Menthol is a substance naturally found in mint plants, such as peppermint and spearmint. It
gives a cooling sensation and is often used to relieve minor pain and irritation. The present
invention has proven analgesic and soothing properties that help relieve from abdominal pain
and low back pain.
Camphor:
Camphor (Cinnamomum camphora) is a terpene (organic compound) that's commonly used in
creams, ointments, and lotions. Camphor oil is the oil extracted from the wood of camphor trees
and processed by steam distillation. It can be used topically to relieve pain, irritation, and it acts
as anesthetic Camphor helps relieve from abdominal pain and low back pain.
Boswelia serrata:
9
Boswellia serrata is a plant that produces Indian frankincense. It is also known as Indian oli-banum,
Salai guggul, and Sallaki in Sanskrit. The plant is native to much of India and the Punjab region that
extends into Pakistan. Boswellia serrata contains various derivatives of boswellic acid including
β-boswellic acid, acetyl-β-boswellic acid, 11-keto-β-boswellic acid and acetyl-11-keto-β5 boswellic acid. Boswellia is taken by mouth for joint pain, painful menstruation. Boswellia is also
used as a stimulant. This plant helps in relaxing the smooth muscles by inhibiting acetylcholine
induced contractions. It also acts on Lipoxygenase path way and inhibits HLE thus reduces pain.
In preferred embodiment of the present invention, a Polyherbal topical Menstrual cramp
relief oil formulation comprising of;
a. 1000mg of Eucalyptus oil;
b. 50mg of Clove oil;
c. 50mg of Menthol;
d. 50 mg of Camphor;
e. 150mg of Boswelia serrata;
f. 500 mg of Iso Propyl Myristate;
g. 1 mg of Butylated Hydroxy Toluene;
h. 0.1250mg of Pain Relief/FFF-88194 (ELVIS);
i. q. s to 5 ml of Light liquid paraffin.
In another embodiment, A polyherbal topical Menstrual cramp relief oil formulation obtained
by a process comprising the steps of;
a. Preparing oil Phase Preparation by taking dispensed quantity of Nilgiri oil (Eucalyptus
globulus) Leaf, Kunduru Oil (Boswellia serrata) /Shallaki Oil, Lavang Oil (Syzygium
aromaticum) Flower bud/ and mixing it for 15 min with continuous stirring in a S.S vessel;
b. Adding of Kapura & Pudina Crystal by adding dispensed quantity of Kapur Crystals
(Cinnamomum camphora) & Pudina Ka Phool (Menthol Crystals) into oil phase of step
(a) with continuous stirring till all the crystals dissolves completely into oil in S.S. vessel;
c. Adding of Iso Propyl Myristate (IPM) and Butylated Hydroxy Toluene in step no. (a) under
continuous stirring till Butylated Hydroxy Toluene dissolves completely for 25-30min;
d. Adding of Fragrance (Pain Relief/FFF-88194 (ELVIS) in Step no. (a) under continuous
stirring and mixing it well;
e. Making volume up to 5.0 Ltr. with Light Liquid Paraffin followed by Filtration in which the
prepared Oil is filtered with mesh 200 nylon cloth & collecting in storage vessel.
In another embodiment of the present invention, binding agents are selected from the
group of isopropyl alcohol, hydroxypropyl cellulose (HPC); xylitol, gelatin; polyvinyl
pyrrolidone (PVP), polyethylene glycol (PEG); water or alcohol; methyl cellulose,
polyvinylpyrrolidone and polyethylene glycol sucrose, lactose; starches, cellulose; Iso
Propyl Myristate, Butylated Hydroxy Toluene, Pain Relief/FFF-88194 (ELVIS), and Light
liquid paraffin.
In another embodiment, binding agents are selected from the group of Iso Propyl Myristate,
Butylated Hydroxy Toluene, Pain Relief/FFF-88194 (ELVIS), and Light liquid paraffin.
In another embodiment, 800- 1000mg is in the concentration range of Eucalyptus oil; 30-50mg
is in the concentration range of Clove oil; 30-50mg is in the concentration range of Menthol; -
50 mg is in the concentration range of Camphor; 120-150mg is in the concentration range of
Boswelia serrata and Iso Propyl Myristate is in the concentration range of 400-500mg; Pain
Relief/FFF-88194 (ELVIS) is in the concentration range of 0.1000-0.1250 mg; Butylated Hydroxy
Toluene is in the concentration range of 0.5-1 mg.
In one embodiment, the topical menstrual cramp relief oil formulation may then be
transferred to a suitable application device such as for example a roll-on device, which
allows for an easy, application. The pain relief formulation is topically administered to a
subject at a location proximal to the said pain.
The present invention resides in an applicator device comprising the pain relief formulation
according to the above embodiments, an applicator device and instructions for using said
formulation to provide pain relief. The applicator device can be any device that ensures correct
and targeted delivery of the pain relief formulation. Examples of appropriate devices include
applicators which attach to a single- or multi-dose container of the formulation, tubes, roll-on
11
devices or droppers. Preferably, the applicator device is a roll-on device. The applicator device
may also include instructions for how to use the formulation, where the instructions typically
include information about how to apply the formulation, dosing schedules etc. For example, the
instructions may be printed on a substrate, such as paper or sticker etc. As such, the instructions
may also be present in the pack as a package insert, in the labeling of the container etc.
Experimental data:
The present study has been planned to study the efficacy and safety of a polyherbal
Menstrual Cramp Relief oil formulation of the present invention. Ninety female participants
divided into 3 arms of 30 in each arm. A total of female study participants who are
Serum fibrinogen
2. Urine routine.
3. Biochemical parameters – Random blood sugar, CRP, Urea, Creatinine, Bilirubin, AST &
ALT (LFT).
4. Microbiological parameter- HIV and HBsAg.
5. Previous Ultra sonogram (USG) abdomen and pelvis reports (for diagnosing PCOS and
Fibroid). If patients had old reports (within 6 months duration), it was not repeated. All the
above tests were done during baseline screening. Demographic data including name, sex,
age, body weight (Kg) and height (m) in terms of BMI, body build, tobacco use and medical
and menstrual histories of participants were recorded. Each subject will undergo thorough
general and systemic examination.
Inclusion criteria:
1. Female participants between the age of 18-50 years (both inclusive) with regular/irregular
menstrual cycles who are clinically diagnosed to have primary dysmenorrhea.
12
2. Subjects with stable vitals like pulse and blood pressure
3. Patient should have not participated in any other clinical trial during the past 3 months.
4. Participants who are willing to give written, signed and dated informed consent to
participate in the study.
5 Exclusion Criteria:
1. Secondary dysmenorrhea
2. History of presence of any other Gynecological diseases.
3. Pregnant or breastfeeding or planning to become pregnant during the study period.
4. Known case of Hypersensitivity to any of the Investigational drug content.
5. Patients suffering from abnormal hematological or biochemical (renal & liver function)
blood parameters.
6. Received any other investigational medicine within 7 days prior to screening which can
interfere with investigational product activity.
7. Suffering from any illness which will interfere with present study as decided by clinical
15 investigator.
The preferred dose of the film coated (premenstrual syndrome)tablets of the present
invention is one tablet thrice daily orally 3 days before menses in both arm 1 & 2.
Participants were randomized into 3 groups (2 test and 1 comparator product) with 30 in
each group.
Group 1- Participants with Primary dysmenorrhea took one tablet of premenstrual syndrome
tablet orally thrice daily 3 days before menses followed by herbal tea granules extract twice
daily for a period of 5 days during the menstrual cycle. All the study participants who satisfy
the study criteria were included in the study. They underwent standard treatment appropriate
to their illness as per the standard management guidelines.
13
Group 2: Participants with primary dysmenorrhea will take one tablet of premenstrual
syndrome tablet orally thrice daily three days before menses followed by topical
application of cramp relief roll on oil on the pain affected lower abdomen, thigh and lower
back three times daily for a period of 5 days during the menstrual cycle.
Group 3: Participants with primary dysmenorrhea will take tablet MEFTAL spas orally 2 times
daily for a period of 5 days during the menstrual cycle.
Evaluation Criteria
The primary outcome measures to study the efficacy are as follows:
1. Change from baseline in menstrual pain intensity measured by Pain VAS Scale (0-
10)
Time Frame: Day 0- Day 5
Testing Interval: Day 0, Day 3, Day 5
2. Changes from base line in following laboratory parameter(s):
• Prostaglandin (PGF2α) – Directly proportional marker for etiology of Primary
15 Dysmenorrhea
• Hs-C Reactive Protein
• ESR
• Serum fibrinogen
• Complete Blood Count
• Renal Function Tests
• Liver Function Tests
Time Frame: Day 0- Day 5
Testing Interval: Day 0, Day 5
14
3. Duration for pain relief in hours (After medication)
Time Frame: Day 0- Day 5
Testing Interval: Day 0, Day 3, Day 5(Through Patient diary)
4. Changes from base line in Quality of life- Questionnaires (Short Form Health-12).
5 Time Frame: Day 0- Day 5
Testing Interval: Day 0, Day 5
5. Change in the Pre-menstrual syndrome assessment questionnaire (ACOG PMS
Questionnaire) and compare it with other group (arm 3)
Time Frame: Day 0- Day 5
Testing Interval: Day 0, Day 5
The secondary outcome measures to assess the safety and tolerability of the study drugs
by monitoring any adverse events during the study period using clinical and laboratory
Evaluation.
Safety and tolerability evaluation criteria:
15 • Adverse events and serious adverse events during the study period
• Laboratory (hematology and biochemistry) parameters (if any)
• Brief clinical examination
• Vital signs (pulse rate, respiratory rate, systolic and diastolic blood pressure, and
body temperature)
20 Time Frame: Day 0- Day 5
Testing Interval: Day 0, Day 5

A statistically significant improvement (using SPSS software version 23.0) in the clinical
parameters along with the study specific efficacy parameters at the end of the study will
prove the efficacy and safety of oral polyherbal fixed dose formulation in the management
of Primary Dysmenorrhea and Premenstrual Syndrome.
Participant monitoring
Participants were monitored throughout the study. The basic hematological and biochemical
parameters were checked on screening and at the end of the study. Any adverse reactions
due to the study formulations and/or study procedures were recorded and reported as per
the latest regulatory guidelines.
The results are as follows:
Table 1 shows Change from baseline up to Day 5 in menstrual pain intensity measured
by Pain VAS Scale:
Table 1

There is a significant reduction in the VAS score in all the three groups after treatment on
day 3 and 5. It is more evident in group 1 and 2 on day 5.
Table 2 shows change in duration (time taken) for pain relief (menstrual pain) from baseline
up to Day 5 in minutes.
16
Table 2
Changes from base line in quality of life –questionnaires. There is no significant
5 abnormalities detected post intervention, in any other laboratory parameters like
pathological and biochemical investigations. There is no renal or hepatotoxicity with respect
to any of the test drugs involved in the study.
On day 5: The time taken for onset of pain relief was early at around 6 minutes in group 2
followed by group 1 with 7.5 minutes and group 3 with 9 minutes.
On day 3: The time taken for onset of pain relief was early at around 45 minutes in group 3
Followed by group 1 with 50 minutes and group 2 with 54 minutes.
On day 0: The time taken for onset of pain relief was early at around 124 minutes in group
3 followed by group 1 with 127 minutes and group 2 with 140 minutes.
Table 3 shows change from base line up to day 5 in the inflammatory marker (ESR):
17
Table 3
There is a significant reduction in ESR levels in all the three groups on day 5 compared to
day 0. Table 4 shows change from base line up to day 5 in the inflammatory marker (Hs
5 CRP).
Table 4
There is a significant improvement (reduction) in the Hs CRP levels on day 5 compared to
day 0, which is more evident in group 1 followed by group 3 & 2 respectively.
Table 5 shows change from base line upto day 5 in the inflammatory marker (PGF2α).
18
Table 5
There is a significant improvement (reduction), in the PGF2α levels in all the three groups
on day 5 compared to day 0.
Table 6 shows change from base line upto day 5 in the inflammatory marker (Serum
Fibrinogen).
Table 6
There is a significant improvement (reduction), in the serum fibrinogen levels, on day 5
compared to day 0, which is more evident in group 1 followed by group 3 & 2 respectively.
19
Table 7 shows other blood parameters of different groups on day 0 and day 5.
5 Table 7
Table 8 shows changes from base line in quality of life –questionnaires. There is no
significant abnormalities detected post intervention, in any other laboratory parameters like
pathological and biochemical investigations. There is no renal or hepatotoxicity with respect
to any of the test drugs involved in the study.

21
Table 8
-P value <0.05. There is a significant improvement in the mean percentage scores of quality
of life-questionnaires after treatment on day 5, which is more evident in group 1 and 2. There
5 is a significant improvement in the overall health status as very good and excellent in group
1 with 57% and group 2 with 52% participants when compared to group 3 with 40% of
participants.
There is also a significant improvement in the overall physical activity status with no
limitations in group 1 with 83% and group 2 with 83% participants when compared to group
3 with 66% of participants.
Table 9 shows change in the pre-menstrual syndrome assessment questionnaire –Mean
scores before and after treatment (ACOGPMS questionnaire).
22
Table 9
-P value<0.001. There is a significant improvement in the means cores of pre-menstrual
syndrome assessment questionnaire after treatment in group 1 and group 3, both at the
baseline and at the end of the treatment. There is a good improvement in the premenstrual
(psychological aspect) symptoms like anxiety,irritability and mood swings in group 1 & 2
compared to group 3 and also with respect to premenstrual (physical aspect) symptoms like
headche,fatigue, and dizziness there is a good improvement in group 1 and 2 compared to
group 3.
Table 10 shows change in the pre-menstrual syndrome questionnaire- total mean scores
before and after treatment (ACOG: PMS questionnaire).
23
Table 10
P value<0.001. There is a highly significant improvement in the total means scores of premenstrual syndrome assessment questionnaire after treatment in group 1 and group 2. The
pre-menstrual symptoms have come down in group 1 and 2 on treatment with premenstrual
syndrome tablet which is not evident meftal spas treated group.
Observations:
From this study, it is evident that polyherbal menstrual cramp relief oil formulation is effective
and safe for menstrual pain and primary dysmenorrhea disorders. It has shown a very quick
onset of action and reduction in menstrual pain, on day 0 and better than all other prior art
products (Meftal spas) on day 5.
The polyherbal menstrual cramp relief oil formulation of the present invention gives better
pain relief in primary dysmenorrhea, better improvement of inflammatory markers, simple
dose determination, and are easy for patients to use. It also lowers the risk of systemic
adverse events, drug-drug interactions and thus provides a good patient compliance. So in
terms of efficacy and adverse effects, this polyherbal menstrual cramp relief oil formulation
is superior as compared to other conventional routes for treatment.

We claim:
1) A polyherbal menstrual cramp relief oil formulation with active ingredients and
pharmaceutically acceptable excipients (binding agents) comprising of;
a. 1000mg of Eucalyptus oil;
b. 50mg of Clove oil;
c. 50mg of Menthol;
d. 50 mg of Camphor;
e. 150mg of Boswelia serrata;
f. antioxidant such as 1 mg of Butylated Hydroxy Toluene;
g. 500 mg of Iso Propyl Myristate;
h. 0.1250mg of Pain Relief/FFF-88194 (ELVIS); and
i. q. s to 5 ml of Light liquid paraffin
2)The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
Eucalyptus oil is in the concentration range of 800- 1000mg.
3) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
15 Clove oil is in the concentration range of 30-50mg
4) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
Menthol is in the concentration range of 30-50mg.
5) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
Camphor is in the concentration range of 30-50 mg.
6) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
Boswelia serrata is in the concentration range of 120-150mg.
7) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the
said polyherbal menstrual cramp relief oil formulation is obtained by a process comprising
the steps of;

a. Preparing oil Phase Preparation by taking dispensed quantity of Nilgiri oil (Eucalyptus
globulus) Leaf, Kunduru Oil (Boswellia serrata) /Shallaki Oil, Lavang Oil (Syzygium
aromaticum) Flower bud/ and mixing it for 15 min with continuous stirring in a S.S vessel;
b. Adding of Kapura & Pudina Crystal by adding dispensed quantity of Kapur Crystals
(Cinnamomum camphora) & Pudina Ka Phool (Menthol Crystals) into oil phase of step
(a) with continuous stirring till all the crystals dissolves completely into oil in S.S. vessel;
c. Adding of Iso Propyl Myristate (IPM) and Butylated Hydroxy Toluene in step no. (a) under
continuous stirring till Butylated Hydroxy Toluene dissolves completely for 25-30min;
d. Adding of Fragrance (Pain Relief/FFF-88194 (ELVIS) in Step no. (a) under continuous
stirring and mixing it well;
e. Making volume up to 5.0 Ltr. with Light Liquid Paraffin followed by Filtration in which the
prepared Oil is filtered with mesh 200 nylon cloth & collecting in storage vessel.
8) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
binding agents are selected from the group of isopropyl alcohol, hydroxypropyl
cellulose (HPC); xylitol, gelatin; polyvinyl pyrrolidone (PVP), polyethylene glycol (PEG);
water or alcohol; methyl cellulose, and polyethylene glycol sucrose, lactose; starches, cellulose;
Iso Propyl Myristate, Pain Relief/FFF-88194 (ELVIS), and Light liquid paraffin.
9) The polyherbal topical menstrual cramp relief oil formulation as claimed in claim 1, wherein
the said binding agents are preferably selected from the group of Iso Propyl Myristate, Pain
Relief/FFF-88194 (ELVIS), and Light liquid paraffin.
10) The polyherbal topical menstrual cramp relief oil formulation as claimed in claim 1, wherein
the said Iso Propyl Myristate is in the concentration range of 400-500mg.
11) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the said
Pain Relief/FFF-88194 (ELVIS) is in the concentration range of 0.1000-0.1250 mg.
12) The polyherbal menstrual cramp relief oil formulation as claimed in claim 1, wherein the
said Butylated Hydroxy Toluene is in the concentration range of 0.5-1 mg.
13) The polyherbal topical menstrual cramp relief oil formulation as claimed in claim 1,
wherein the said formulation is an oil, gel, lotion, lubricant.
26
14) The polyherbal topical menstrual cramp relief oil formulation as claimed in claim 1,
wherein the said formulation is preferably oil.
15) An applicator device comprising the menstrual cramp relief oil formulation as claimed in
claim 1 to 13, or produced as per process as claimed in claim 7, wherein the said applicator
device using said formulation, to provide pain relief to a subject (human )in need thereof.
16) The applicator device as claimed in claim 14, wherein the applicator device is a roll-on
device.