| CTRI Number |
CTRI/2026/02/103553 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Clinical ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare effectiveness of Trivrutta oil and Sahacharadi oil in relieving Menstrual Pain |
|
Scientific Title of Study
|
An open labelled randomised clinical study to evaluate the efficacy of Trivrutta tail Matra basti in comparison with Sahacharadi tail Matra basti in the management of Udavarta yonivyapada wsr. to Primary Dysmenorrhoea |
| 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 Archana Dnyaneshwar Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr D Y Patil Deemend to be University |
| Address |
D Y Patil Ayurvedic Hospital 1st floor Prasutitantra & Streerog Department OPd No. 8, Sector 7 Nerul East, Navi Mumbai.
D Y Patil Ayurvedic Hospital 1st floor Prasutitantra & Streerog Department OPd No. 8, Sector 7 Nerul east, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9820889891 |
| Fax |
|
| Email |
drarchanabahalkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana Dnyaneshwar Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr D Y Patil Deemend to be University, Scholl of Ayurveda |
| Address |
D Y Patil Ayurvedic Hospital, 1st Floor, Prasutitantra and Streerog Department OPD No. 8, Sector 7 Nerul East, Navi Mumbai
D Y Patil Ayurvedic Hospital, 1st Floor, Prasutitantra and Streerog Department OPD No. 8, Sector 7 Nerul East, Navi Mumbai
Thane
MAHARASHTRA
400086
India |
| Phone |
9820889891 |
| Fax |
|
| Email |
drarchanabahalkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Dnyaneshwar Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr D Y Patil, Deemed To Be University, School Of Ayurveda |
| Address |
D Y Patil Ayurvedic Hospital, 1st Floor, Prasutitantra and Streerog Department OPD No. 8, Sector 7 Nerul East, Navi Mumbai
D Y Patil Ayurvedic Hospital, 1st Floor, Prasutitantra and Streerog Department OPD No. 8, Sector 7 Nerul East, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820889891 |
| Fax |
|
| Email |
drarchanabahalkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Archana Mahajan |
| Address |
Padmashree Dr D. Y. PATIl, Ayurvedic Hospital, 1st Floor, Prasutitantra and Streerog Department Sector 7 Nerul East Navi Mumbai 400706 |
| Type of Sponsor |
Other [] |
|
|
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 Archana Mahajan |
D Y Patil Ayurvedic Hospital |
Padmashree Dr D. Y. PATIL, Ayurvedic Hospital, 1st Floor Prasutitantra and Streerog Department OPD. No. 8, Sector 7 Nerul East Navi Mumbai 400706
Thane
MAHARASHTRA |
9820889891
drarchanabahalkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Padmashree Dr. D Y Patil Deemed to be University School of Ayurveda |
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 | Procedure | - | bastikarma, बस्तिकर्म | (Procedure Reference: Ashtang Sangraha Uttarsthan chapter 39 verse 42, Procedure details: Group A is trial group will receive Trivrutta tail Matra Basti , Group B Control Group will receive Sahacharadi tail Matra Basti
Duration of treatment is 7 days before expected date of menses for 7days & for 3 consecutive cycles. The observation will be made after 5th day of menstrual cycle & conclusion will be made as per the observations found.
)
(1) Medicine Name: Trivrutta Taila, Reference: Ashtang Sangraha Uttarsthan chapter 39 verse 42, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients ready for the study
Female patients of age group 13 to 45 years
Selection will be irrespective of marital status parity and prakruti
Patients suffering from Udavarta Yonivyapada
Sakashta raja pravrutti
Katishul
ubhay-padashul
angamarda
hrulhas.
Rajopravrutti purva udarshul and Rajopravrutti uparant tatkshanam upasham
|
|
| ExclusionCriteria |
| Details |
Pelvic inflammatory disease
Endometriosis
Cervical or uterine fibroid
Patients with any benign or malignant tumor and erosion of reproductive tract
Patients taking any hormonal therapy
Patients with IUCD and on contraceptive pills
Congenital anomalies of reproductive system
Cervical stenosis
Ante natal and post natal patients
Patients with diabetes and hypertension
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Severity of Dysmenorrhea as Measured by Visual Analog Scale |
The observation will be made after 5th day of menstrual cycle and conclusion will be made as per the observations found. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Associated Symptoms of Udavarta Yonivyapad like sakashta artav strav, Raja strav swaroop, hrulhas, malavshtambha, Katishul |
5th day of every Menstrual cycle for 3 consecutive cycles |
|
|
Target Sample Size
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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="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
|
Primary dysmenorrhoea is a common gynaecological condition characterized by painful menstruation without any pelvic pathology In Ayurveda, this condition is comparable to Udavarta Yonivyapad which mainly occurs due to vitiation of Vata dosha Basti therapy is considered the most effective treatment for Vata predominant disorders This study is an open labelled randomized clinical trial planned to evaluate and compare the efficacy of Trivrutta Tail Matra Basti and Sahacharadi Tail Matra Basti in the management of Udavarta Yonivyapad with special reference to primary dysmenorrhoea. Eligible participants will be randomly divided into two groups. Group A will receive Trivrutta Tail Matra Basti and Group B will receive Sahacharadi Tail Matra Basti 7days prior to expected menstrual date The effect of therapy will be assessed on the basis of reduction in intensity and duration of menstrual pain improvement in associated symptoms and overall clinical response The study aims to determine the comparative effectiveness of both interventions and to provide evidence based Ayurvedic management for primary dysmenorrhoea |