| CTRI Number |
CTRI/2025/11/096907 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two ayurvedic herbal tablets afsanteen and meethi seeds for pain relief during menstrution. |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Afsanteen (Artemisia absinthium Linn. ) Ghana vati verses Methika beej (Trigonella foenum-graecum Linn.) Ghana vati in management of kashtartava (Primary dysmenorrhea) -RCT |
| 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 Mrunal Gawande |
| Designation |
BAMS post graduate |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
First floor,room no 3,department of dravyaguna,Mahatma Gandhi Ayurved College Hospital and Research Centre,Salod(H),Wardha ,442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9112807879 |
| Fax |
|
| Email |
mrunalgawande55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Vidhate |
| Designation |
Assosiate professor,department of dravyaguna |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
First floor,room no 3,department of dravyaguna,Mahatma Gandhi Ayurved College Hospital and Research Centre,Salod(H),Wardha ,442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8552838670 |
| Fax |
|
| Email |
sneha.vidhate@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrunal Gawande |
| Designation |
BAMS post graduate |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
First floor,room no 3,department of dravyaguna,Mahatma Gandhi Ayurved College Hospital and Research Centre,Salod(H),Wardha ,442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9112807879 |
| Fax |
|
| Email |
mrunalgawande55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MGACHRC |
| Address |
Mahatma gandhi ayurved college hospital and research centre,salod,wardha 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mrunal Gawande |
MGACHRC |
Mahatma Gandhi Ayurved college hospital and research centre,salod,wardha ,442001
Wardha
MAHARASHTRA |
9112807879
mrunalgawande55@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,MGACHRC |
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 | Classical | | (1) Medicine Name: Afsanteen, Reference: Commentary of Pandey & Chunekar on Bhavprakash Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Methika beej, Reference: Arka Prakashan by Tripathi, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
Patients with sign and symptoms of primary dysmenorrhea like pain in lower abdomen radiating toward back and legs with associated symptoms like nausea ,headache ,fatigue . |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intensity of pain in primary dysmenorrhea |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Primary dysmenorrhea Kashtartava is a prevalent gynecological disorder affecting adolescent girls, causing significant discomfort and reduced quality of life. Conventional NSAIDs provide relief but are often associated with adverse effects, highlighting the need for safer alternatives. This randomized controlled clinical trial evaluates the comparative efficacy of Afsanteen Artemisia absinthium Linn. Ghana vati and Methika beej Trigonella foenum-graecum Linn.Ghana vati in managing Kashtartava. Fifty participants aged 11 to18 years were randomized into two groups and treated for three consecutive cycles. Outcomes were assessed using VAS and VMS scales. The study aims to provide evidence-based validation of Ayurvedic interventions for primary dysmenorrhea. |