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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary Dysmenorrhea 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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: -
2Comparator ArmDrugClassical(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.

 
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