| CTRI Number |
CTRI/2026/01/100109 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effect of head massage,foot massage and nasal oil application verses Ashwagandha powder in Premenstrual Syndrome. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to evaluate the efficacy of Shiroabhyanga, Padabhyanga and Pratimarsha Nasya compared with Ashwagandha Churna in 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 Arti |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619319603 |
| Fax |
|
| Email |
arti031097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Agrawal |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No 228 Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058697177 |
| Fax |
|
| Email |
drsarvesh1008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arti |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619319603 |
| Fax |
|
| Email |
arti031097@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan, Pin code: 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate Amer road Jaipur Rajasthan Pin code: 302002 |
| 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 Arti |
National Institute of Ayurveda, Jaipur group of hospitals |
OPD No.21 National Institute of Ayurveda Jorawar Singh Gate Amer Road Rahasthan Pin Code - 302002
Jaipur
RAJASTHAN |
8619319603
arti031097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: -, Procedure details: 1. Shiro-abhyanga
2. Pada-abhyanga
3. Pratimarsa Nasya)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Churna, Reference: 10. How To Lower Cortisol Naturally with Supplements, by Kirstyn Hill, PharmD, MPH ,Published on March 3, 2025, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: N.A. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married and unmarried females of age group 20 – 45 years
Patients willing to participate in this trial through written informed consent
Patients fulfilling the criteria of mild to moderate PMS as per PMSS
|
|
| ExclusionCriteria |
| Details |
Females with menstrual irregularities
Menstrual or gynecological disorders such as endometriosis, fibroid
Allergy or hypersensitivity to treatment ingredients
Use of hormonal contraceptives or treatments (birth control pills, hormone replacement therapy within last 3 months)
Severe medical conditions such as Hyperthyroidism (TSH less than 0.1mIU/L), Anemia (Hb less than 7 gm/dl)
Pregnant or lactating women
Lactose intolerance (Because Trial drug Ashwagandha will be administered with milk)
|
|
|
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 PMSS score |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in menstrual pattern |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
RESEARCH QUESTION Is there any difference between the efficacy of Shiroabhyang, Padabhyanga, Pratimarsha Nasya and Ashwagandha Churna in management of PMS (w.s.r. Rituvyatit Kalaja Pitta Vata Vriddhi)? HYPOTHESIS Null Hypothesis [Ho] - There is no difference in the efficacy of Shiroabhyanga, Padabhyanga and Pratimarsha Nasya as compared with Ashwagandha Churna in PMS (w.s.r. Rituvyatit Kalaja Pitta Vata Vriddhi). Alternative Hypothesis [HA] - There is difference in the efficacy of Shiroabhyanga, Padabhyanga and Pratimarsha Nasya as compared with Ashwagandha Churna in PMS (w.s.r. Rituvyatit Kalaja Pitta Vata Vriddhi). AIM To evaluate the efficacy of selected Dinacharya procedures (Shiroabhyanga, Padabhyanga, and Pratimarsha Nasya) in comparison with Ashwagandha Churna in PMS (w.s.r. to Rituvyatit Kalaja Pitta Vata Vriddhi). OBJECTIVE To evaluate the efficacy of Shiroabhyanga, Padabhyanga, and Pratimarsha Nasya in comparison with Ashwagandha Churna in PMS (w.s.r. to Rituvyatit Kalaja Pitta Vata Vriddhi). |