| CTRI Number |
CTRI/2026/03/105769 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Process of Care Changes
Other (Specify) [interventional] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the Effect of Shatapushpaphal Churna In Kashtartava in Udavartini Yonivyapad (Dysmenorrhoea) |
|
Scientific Title of Study
|
Evaluation of the Effect of Shatapushpaphal Churna In Kashtartava with special reference to Udavartini Yonivyapad (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 Supriya |
| Designation |
MS Scholar |
| Affiliation |
Dr. D. Y. Patil college of Ayurved and Research Centre |
| Address |
Opd no 2, Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9960887149 |
| Fax |
|
| Email |
sppawarsupriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smritika Taware |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr. D.Y. Patil college of Ayurved and Research Centre |
| Address |
Opd no 2, Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9850967067 |
| Fax |
|
| Email |
bhonsalesmritika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya |
| Designation |
PG Scholar |
| Affiliation |
Dr. D. Y. Patil college of Ayurved and Research Centre |
| Address |
Opd no 2, Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9960887149 |
| Fax |
|
| Email |
sppawarsupriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Ayurved and Research Centre Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Supriya |
| Address |
Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune,Maharashtra 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Supriya |
Dr. D.Y. Patil college of Ayurved and Research Centre |
Opd and Ipd, Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9960887149
sppawarsupriya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil college of Ayurved and Research Centre Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Anethum theo sowa, Reference: Bhavprakash , Route: Oral, Dosage Form: Churna/ Powder, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
patient suffering from painful menstruation. |
|
| ExclusionCriteria |
| Details |
Known case of secondary Dysmenorrhoea.
Women diagnosed with congenital anamolies of reproductive tract, pelvic infections.
Other medical disorders which make patient at high risk like epilepsy, heart disease, pain due to arthritis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of shatapushpaphal churna in kashtartava which will be assessed by measuring the pain by Visual Analogue Scale. |
effect of shatapushpaphal churna in kashtartava which will be assessed by measuring the pain by Visual Analogue Scale for a period of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Shatapushpa phal churna |
will be measured by visual analogue scale |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
20/03/2026 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THIS IS A SINGLE ARM CLINICAL STUDY THE AIM OF THE STUDY IS TO EVALUATE THE EFFICACY OF SHATAPUSHPA PHAL CHURNA IN KASHTARTAVA WITH SPECIAL REFERENCE TO UDAWARTINI YONIVYAPAD (DYSMENORRHOEA). TOTAL 28 PATIENTS WILL BE ENROLLED AND 250MG OF SHATAPUSHPA PHAL CHURNA WILL BE GIVEN TWICE A DAY AFTER MEAL. THE AGE GROUP TAKEN FOR THE STUDY IS 12 TO 35 YEARS WOMEN. CONSENT WILL BE TAKEN OF ONE OF PARENTS OF PATIENT BELOW 18YEARS OF AGE.THE FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHODS. |