| CTRI Number |
CTRI/2025/05/086558 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study On Effect Of Matra Basti With Guduchyadi Taila And Sahacharadi Taila In Management Of Dysmenorrhea |
|
Scientific Title of Study
|
A Comparative Clinical Study On The Efficacy Of Matra Basti With Guduchyadi Taila And Sahacharadi Taila In The Management Of Udavarta Yonivyapad w.s.r 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 |
Dr Payal Sahuji |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal |
| Address |
Department Of Prasuti Tantra Evum Stri Roga, Third Floor, Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
09130899776 |
| Fax |
|
| Email |
drpayalsahuji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Jadhao |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal |
| Address |
Department Of Prasuti Tantra Evum Stri Roga, Third Floor, Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9762780280 |
| Fax |
|
| Email |
drvarshapadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Jadhao |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal |
| Address |
Department Of Prasuti Tantra Evum Stri Roga, Third Floor, Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9762780280 |
| Fax |
|
| Email |
drvarshapadhav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal, Madhya pradesh, India 462042 |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital And Research Center Kolar Road Bhopal |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third Floor, Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal, 462042 |
| 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 Payal Sahuji |
Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal, 462042 |
Department of Prasuti Tantra Evum Stri Roga, Third Floor, Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal
Bhopal
MADHYA PRADESH |
09130899776
drpayalsahuji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mansarovar Ayurvedic Medical College Hospital And Research Center, Kolar Road, Bhopal |
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 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak Samhita, Procedure details: Matra Basti for 7 days for 3 Consecutive Cycle from Sixth day of Menstrual Cycle)
(1) Medicine Name: Guduchyadi Taila, Reference: Charak Samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak Samhita, Procedure details: Matra Basti for 7 days for 3Consecutive Cycle from Sixth day of Menstraul Cycle)
(1) Medicine Name: Sahacharadi Taila, Reference: Ashtang Hridaya, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
The Pateints Having Classical Symptoms of Udavarta Yonivyapad As Per The Classical References Will Be Selected |
|
| ExclusionCriteria |
| Details |
Patients Giving History of Recent Delivery Or Abortion.
Patients Having Secondary Dysmenorrhea.
Patients Having Vulvo-Vaginal Infections And Pelvic Congestion.
Patients Having Systemic Diseases Like Diabetes, TB, Hypertension etc. Cases With Any Pelvic Pathology (Fibroid, Adenomyosis, Endometriosis etc).
Patients Taking Oral Contraception Pills & With IUCD. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Painful menstruation which affecting the daily activity, Constipation |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CBC
USG-Pelvis |
120 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/05/2025 |
| 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="0"
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
|
Dysmenorrhea is an important clinical as well as social problem affecting more than 50% of menstruating women. A dysmenorrhea is common problem in india with prevalence of 87.7%. In india, the highest number of girls about 42.6% of age 19-20 years are having dysmenorrhea and more than two third of girls about 70.2% having dysmenorrhea as moderate to severe. Guduchyadi and sahacharadi taila matra basti is best therapeutic treatment for vataja vyadhi. The aim of study is to establish an effective, harmless & long-term relief giving ayurvedic formulation to administrate as matra basti in treatment of udavartini yonivyapad. |