| CTRI Number |
CTRI/2025/02/080031 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to know how Methika Granules helps reducing pain in primary dysmenorrhea |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the add on Effectiveness of Methika Granules in Primary Dysmenorrhea |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hridya S |
| Designation |
PG Scholar Dept of Swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan College of Ayurveda Hassan |
| Address |
Dept of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India Dept of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India Hassan KARNATAKA 573201 India |
| Phone |
09400791763 |
| Fax |
|
| Email |
pg23153@sdmcahhassan.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivakumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan College of Ayurveda Hassan |
| Address |
Dept of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India Dept of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India Hassan KARNATAKA 573201 India |
| Phone |
9886259437 |
| Fax |
|
| Email |
drshivakumar@sdmcahhassan.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivakumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan College of Ayurveda Hassan |
| Address |
Dept of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India Dept of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan
573201 Karnataka India Hassan KARNATAKA 573201 India |
| Phone |
9886259437 |
| Fax |
|
| Email |
drshivakumar@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road Thanniruhalla Hassan Karnataka 573201
India |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayyurveda and Hospital BM Road Thanniruhalla Hassan 573201
Karnataka
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hridya S |
SDM College of Ayurveda and Hospital Hassan |
Department of Swasthavritta
BM Road Thanniruhalla Hassan Karnataka 573201 India
Hassan KARNATAKA |
9400791763
pg23153@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Methika Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhanwantari Gutika, Reference: Sahasrayogam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects between the age group of 18-30years
2. Subjects having regular menstrual cycles
3. Subjects who are willing to give consent for the study. |
|
| ExclusionCriteria |
| Details |
1.Acyclic bleeding
2. Any pelvic pathology leading to dysmenorrhea
3. K/C/O Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain
ful periods and improving the lifestyle of individuals. |
1st, 2nd and 3rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in School and office absenteeism |
1st, 2nd and 3rd day |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acharya Kashyapa explored the medicinal potential of Aahar (food) along with its
prophylactic value in maintaining health. He stated that food is the best
medicine, and no drug can match the benefits of food in a diseased state. Only
wholesome food can keep a person healthy.1 Methika
(Trigonella foenum graecum) is one of the oldest known medicinal
plants2 which is commonly used as condiment in many food
preperations3. It is not only used for enhancing the taste of food,
but also provides some preventive health benefits. It
has been associated with reduced severity of dysmenorrhea including menstrual
pain, fatigue, nausea, headache and lack of energy.2 Phytoestrogens
are plant-based compounds4 which aids in hormonal production5.
Diosgenin and trigonellin are the primary chemical constituents
of Methika considered as phytoestrogen causes variation in the release
of estrogen and progesterone leading to regulated uterine contractions and
controlled release of prostaglandins and thereby pain. This shows the
Antispasmodic and Spasmolytic activity of Methika. The ability of Methika
to prevent platelet aggregation causes liquefaction of menstrual blood clots
avoids excessive muscular contractions which is another cause of dysmenorrhea.5
Primary
dysmenorrhea is a condition which causes painful menstrual cramps without
pelvic pathology.6 In India the
estimated prevalence of primary dysmenorrhea reported in 2023 is 85.28%7. In various studies adolescents with
primary dysmenorrhea report that it affects their academic performance, social
and sports activities8. In severe cases it results in absenteeism
from work or School6 and is a common cause of reduced quality of
life in women.9 The most common issue of menstrual problems on daily
routine were reported by students and unmarried women, with prolonged resting
hours followed by inability to study.8 In fact, it is estimated that
each year due to dysmenorrhea, over 600 million working hours are lost. Such
absences lessen the opportunities for successful educational, psychosocial and
cognitive development during adolescent growth.8 Lifestyle plays an
important role in maintenance of health9. Faulty
lifestyle adoptions such as- stress, not being physically active, eating and
sleeping at irregular intervals etc are all the factors contributing to
increased prevalence of the condition.9 In present era, as
dysmenorrhea is a burning problem and population of dysmenorrheal women is
increasing day by day, there is a need to solve this problem. Methika
being cost effective, readily available in households and its capacity to
retain its properties in dry form, it will be formulated in the form of
granules to make it as palatable, easy for consumption and its add-on
effectiveness in management of primary dysmenorrhea will be assessed. |