| CTRI Number |
CTRI/2026/03/105490 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [SATVAVAJAYA CHIKITSA ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF SHATAPUSHPA TAILA PRATIMARSHA NASYA AND SATVAVAJAYA CHIKITSA IN MANAGING PREMENSTRUAL SYNDROME |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFECT OF SHATAPUSHPA TAILA PRATIMARSHA NASYA WITH SATVAVAJAYA CHIKITSA IN THE MANAGEMENT OF PREMENSTRUAL SYNDROME |
| 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 Amita Choudhary |
| Designation |
PG SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur ROAD Karwar Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636230266 |
| Fax |
|
| Email |
dr.amita3187@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur ROAD Karwar Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9782371381 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Choudhary |
| Designation |
PG SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur ROAD Karwar Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636230266 |
| Fax |
|
| Email |
dr.amita3187@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dsrrau Jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduation institute of Ayurved DSRRAU Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur |
| 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 Amita Choudhary |
Post Graduation institute of Ayurved DSRRAU Jodhpur Rajasthan |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate
Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved
University Nagaur Road Karwar Jodhpur
Jodhpur
RAJASTHAN |
9636230266
dr.amita3187@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Post graduate instiute of Ayurveda Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere. 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: SHATAPUSHPA TAILA , Reference: Kasyap Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Weeks, anupAna/sahapAna: No, Additional Information: Patient given nasya for two Consecutive cycler. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Age of patient between 18-40 years, Married/unmarried patients with Regular Menstrual Cycle history (21-35 days) suffering from Premenstrual Syndrome showing the Premenstrual Syndrome Scale Total Score equal or more than 80
2.Symptom severity: Women experiencing moderate to severe PMS symptoms interfering with daily routine, interpersonal relationships, or occupational performance.
3.Willing to participate and able to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients having Irregular cycles.
2.Pregnancy, lactating mother.
3.Patients using hormonal contraceptives or Intra uterine devices in last 3 months.
4.Premenstrual Dysphoric Disorder diagnosis or major psychiatric illness.
5. Patients having Thyroid, Diabetes and Endometriosis.
6.Severe systemic disease (cardiac, renal, hepatic, neurological).
7.Patient currently using antidepressants, anxiolytics, or steroids.
8.Patients who are contraindicated for Nasya therapy such as nasal polyp, nasal bleeding,
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of PREMENSTRUAL SYNDROME SCALE
Assessment of Physiological, Psychological and behavioral symptoms
|
60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in classical symptoms of Premenstrual syndrome
• Improvement in Visual Analogue Scale
• Analytical study will be done on Shatapushpa taila at DTL lab DSRRAU , Jodhpur .
|
60 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="0"
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 is Single group CLINICAL STUDY TO EVALUATE THE EFFECT OF SHATAPUSHPA TAILA PRATIMARSHA NASYA WITH SATVAVAJAYA CHIKITSA IN THE MANAGEMENT OF PREMENSTRUAL SYNDROME. The research will be performed on 50 Premenstrual Syndrome patients who have been clinically diagnosed and confirmed, and these patients will be recruited in the study.These 50 PATIENTS WILL BE TREATED WITH SHATAPUSHPA TAILA PRATIMARSHA NASYA. Nasya Given Once a day, for 7 days from 18th day of cycle till 24 th day of cycle.In Satvavajaya Chikitsa Counselling done for 4 sessions in every 15 days and Yoga done for 2 Consecutive cycles.
|