| CTRI Number |
CTRI/2025/04/085548 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Group A Saptasara Kashaya Group B Sahacharadi Taila matrabasti] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on Saptasara kashaya and Sahacharadi taila matrabasti in the management of primary dysmenorrhea |
|
Scientific Title of Study
|
Randomized comparitive clinical trial on Saptasara kashaya and Sahacharad taila matrabasti in the management of udavartini yonivyapad with special reference to 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 |
VISHNUPRIYA THANKACHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
National Institute Of Ayurveda
Department of Rachna Sharira
Room Number 116 Jaipur Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9747586618 |
| Fax |
|
| Email |
vishnupriya1996vishnu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sunil Kumar |
| Designation |
Professor |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
National Institute Of Ayurveda
Department of Rachna Sharira
Room Number 105 Jaipur Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9747586618 |
| Fax |
|
| Email |
drsunilkumarbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VISHNUPRIYA THANKACHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
National Institute Of Ayurveda
Department of Rachna Sharira
Room Number 116
Jaipur Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9747586618 |
| Fax |
|
| Email |
vishnupriya1996vishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA
Madhav Vilas Place Jorawar singh gate
Amer Road Jaipur Rajasthan India Pin 302002 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
NATIONAL INSTITUTE OF AYURVEDA
Madhav Vilas Place Jorawar Singh Gate
Amer Road Jaipur Rajasthan India PIN 302 002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VISHNUPRIYA THANKACHAN |
National Institute Of Ayurveda Jorawar singh gate Amer Road Jaipur Rajasthan India Pin 302002 |
Department Of Prasuti Tantra and Stree roga OPD 26 and 27 Dept of Sharir rachna sharir OPD 3
Jaipur
RAJASTHAN |
09747586618
vishnupriya1996vishnu@gmail.com |
| VISHNUPRIYA THANKACHAN |
NIA,OPD and IPD |
NATIONAL INSTITUTE OF AYURVEDA MADHAV VILAS PALACE JORAWAR SINGH GATE AMER ROAD 302002
Jaipur
RAJASTHAN |
9747586618
vishnupriya1996vishnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SAPTASARA KASHAYA, Reference: SAHASRAYOGA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -GUD AND SAINDHAVA), Additional Information: - | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Ashtanga hridaya Uttarasthana 24/22, Procedure details: 60 ml taila is given late noon soon after meal via anal route once a day for consecutive 7 days before expected date of menstruation )
(1) Medicine Name: Sahacharadi taila , Reference: Ashtangahridaya Chikitsa 21/67, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
Patients with primary dysmenorrhea or udavartini yonivyapad and associated symptoms
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed with pelvic pathology
Patients under hormonal therapy
Any other systemic illness
Carcinoma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in score of visual analogue scale |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in score of verbal descriptive scale |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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 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
|
This study critically examines Artavavaha Srotas, a concept uniquely described by Acharya Susruta, and its relevance to Udavartini yonivyapad, caused by Vegadharana, leading to upward movement of morbid Raja, which aligns with primary dysmenorrhea in modern medicine. With over 50% of women experiencing menstrual discomfort and a significant percentage being incapacitated, the research highlights the need for effective Ayurvedic interventions. It aims to compare the therapeutic efficacy of Saptasara Kashaya (oral) and Sahacharadi Taila Matrabasti in managing pain and associated symptoms. Saptasara Kashaya, mentioned in Sahasrayoga, contains ingredients known for Vatanulomana, Deepana, Pachana, and Srotoshodhana properties, acting specifically on Apana Sthana. Sahacharadi Taila, used in vata vyadhi chikitsa, aids Apana Vayu Anulomana and is beneficial for treating Yonirogas. Since Basti as a main mode of chikitsa emphasized in yonirogas for Vata anulomana, its role in Udavartini Yonivyapad chikitsa is crucial. Addressing a significant research gap, this study investigates whether these treatments provide differential efficacy in pain relief and symptom management, contributing to a scientifically validated approach for improving women’s reproductive health. |