| CTRI Number |
CTRI/2024/11/077327 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| 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
|
Relieving menstrual pain with modified shoolharan yoga and Trilokya vijaya tablet |
|
Scientific Title of Study
|
Clinical evaluation of modified Shoolharan yoga and Trilokya Vijaya Vati in 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 Khem Chand Sharma |
| Designation |
HOD Professor |
| Affiliation |
Rishikul Campus , Haridwar , Uttarakhand Ayurved University |
| Address |
PG Department of Rasa Shastra Evam Bhaishajya Kalpana Rishikul Campus , Haridwar , Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8006945015 |
| Fax |
|
| Email |
drkhemchand.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khem Chand Sharma |
| Designation |
HOD Professor |
| Affiliation |
Rishikul Campus , Haridwar , Uttarakhand Ayurved University |
| Address |
PG Department of Rasa Shastra Evam Bhaishajya Kalpana Rishikul Campus , Haridwar , Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8006945015 |
| Fax |
|
| Email |
drkhemchand.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus , Haridwar , Uttarakhand Ayurved University |
| Address |
PG Department of Rasa Shastra Evam Bhaishajya Kalpana Rishikul Campus , Haridwar , Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6395208998 |
| Fax |
|
| Email |
ashishkumarsai01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Uttarakhand Ayurved University Haridwar,District-Haridwar, Country - India ,Pin code- 249401, State- Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Uttarakhand Ayurved University |
| Address |
Rishikul Campus, Uttarakhand Ayurved University ,Haridwar, District-Haridwar, State- Uttarakhand , Country- India , Pin code- 249401 |
| Type of Sponsor |
Government 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 Ashish kumar |
Rishikul ayurvedic hospital, Haridwar |
OPD No-9 Department of Prasuti tantra evum stri roga, Rishikul college campus
Hardwar
UTTARANCHAL |
6395208998
ashishkumarsai01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Uttarakhand Ayurved University, Rishikul Campus Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: SHYBE, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -SHYBE (Extract of Shoolharan Yoga Potentiated with bhavana of shoolprashaman mahakashaya) | | 2 | Comparator Arm (Non Ayurveda) | | - | Meftal Spas | Dose-500mg frequency- intially 500mg is given once followed by 250 mg every 6-8 hours total duration - the scheduled dose should not exceed more than 3 days , route- oral | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trilokya vijaya vati, Reference: Rasa trangani 24/427-430, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Female Patients married /unmarried of age group 12-45 year will be selected.
2. Pain should be cardinal features.
3. Patients with the complaint of Dysmenorrhea from at least two consecutive cycles which last upto few hours to few days.
4.Patients irrespective of the religion, occupation having fair general condition will be selected for the study.
|
|
| ExclusionCriteria |
| Details |
1. Dysmenorrhea which require emergency intervention such as faint, acute abdomen pain.
2. Menorrhagia, Metrorrhagia patients should be excluded.
3.Patients existing with disease of cardiovascular, renal or hematopoietic systems and
mental diseases will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dose and Duration required to relieve mild to moderate pain in the Dysmenorrhea will be assessed on the basis of WaLIDD score. |
Outcome will be evaluated after 3 days of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of improvement in frequency and duration of pain will be assessed |
within 72 hours of administration of drug |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/01/2025 |
| Date of Study Completion (India) |
20/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashishkumarsai01@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Type of Study :Interventional Level of Study :OPD Level(Single Blind Triple arm)
Duration of Treatment : 9 doses in the 72 hours from the onset of the pain during menstural phase. Method of Treatment/Intervention Selected Drugs: 1. Tab. SHYBE (Extract of Shoolharan yoga potentiated with bhavana of Shoolprashaman Mahakashaya) 2. Tab. Trilokya Vijaya Vati( GMP Certified) 3. Tab.Meftal-spasTM Form of Medicine :Tablet Dose of Drug: 1. Tab. SHYBE 500 mg TDS 2. Tab. Trilokya Vijaya Vati 125 mg TDS 3. Tab.Meftal-spasTM (Mefenamic acid 250 mg & Dicycloamine10 mg)TDS Route of Administration: Oral Preparation And Storage of Medicine The medicine will be prepared under strict aseptic procedure. Tablets from the extract of Shoolharan Yoga bhavit with Shoolprashaman Mahakashaya (SHYBE) will be prepared. The tablets will be stored in air tight containers. Procedure The selected patients for trial will be randomly divided into following three groups (20 patients in each group) | S. No. | GROUPS | DRUG | DOSE(As Per classical) | | 1 | Group A | Tab. SHYBE | 500 mg | | 2 | Group B | Tab. TVV | 125 mg | | 3 | Group C | Tab. Meftalspas | 200 mg | Assessment - It will be done after 30 min, 1hr after drug intake on the basis of Visual Analogue Scale before treatment and after drug intake.
- Assesment of result of Therapy after 3 days on the basis of WALIDD Score.
Follow Up The follow up will be done after 72 hr. |