| CTRI Number |
CTRI/2026/04/107620 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to evaluate the efficacy of Chaturbeeja Churna with and without classical menstrual regimen on Premenstrual Syndrome |
|
Scientific Title of Study
|
Randomized comparative clinical trial to evaluate the efficacy of Chaturbeeja Churna with and without Rajaswala Paricharya on 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 |
Diksha Khathuria |
| Designation |
Ph.D. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College, Udaipur |
| Address |
PG Department of Prasuti Tantra Evam Striroga, Madan Mohan Malviya Govt. Ayurved College, Ambamata, Udaipur
Flat No. 214, Vinayak Residency, Keshav Nagar, 313001
Udaipur
RAJASTHAN
313002
India |
| Phone |
9413727680 |
| Fax |
|
| Email |
diksha.khathuria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anu M S |
| Designation |
Lecturer |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College, Udaipur |
| Address |
PG Department of Prasuti Tantra Evam Striroga, Madan Mohan Malviya Govt. Ayurved College, Ambamata
OPD No. 6, Govt. Ayurved Hospital, Motichohatta
Udaipur
RAJASTHAN
313002
India |
| Phone |
8281801649 |
| Fax |
|
| Email |
dranuvaidhya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu M S |
| Designation |
Lecturer |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College, Udaipur |
| Address |
PG Department of Prasuti Tantra Evam Striroga, Madan Mohan Malviya Govt. Ayurved College, Ambamata
OPD No. 6, Govt. Ayurved Hospital, Motichohatta
Udaipur
RAJASTHAN
313002
India |
| Phone |
8281801649 |
| Fax |
|
| Email |
dranuvaidhya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt. Ayurved College, Radaji Circle Udaipur, Rajasthan, India 313002 |
|
|
Primary Sponsor
|
| Name |
Diksha Khathuria |
| Address |
PG Department of Prasuti Tantra Evam Striroga, Madan Mohan Malviya Govt. Ayurved College, Udaipur, Rajasthan, India 313001 |
| 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 Anu MS |
M.M.M. Govt. Ayurveda College, Udaipur |
OPD No. 6, Govt. Ayurved Hospital, Motichohatta, Udaipur, 313001
Udaipur
RAJASTHAN |
8281801649
dranuvaidhya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madan Mohan Malviya Govt. Ayurved College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N943||Premenstrual tension syndrome. 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: Chaturbeeja Churna, Reference: Bhavaprakash Nighantu, Hareetakyadi Varga 88,89, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: With Rajaswala Paricharya | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chaturbeeja Churna, Reference: Bhavaprakash Nighantu, Hareetakyadi Varga 88,89, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Regular menstrual cycle of 21–35 days
Women (married or unmarried) who are able to sign informed consent and demonstrate cooperative behaviour
Fulfilling American College of Obstetrics Gynecology criteria for PMS
Willing to participate and comply with treatment and follow up for the 2 month duration of the study
|
|
| ExclusionCriteria |
| Details |
Irregular menstrual cycles
Symptoms present for less than 2 cycles
Participation in any clinical trial within 1 month
Currently pregnant or breastfeeding
History of mental disorders or ongoing psychiatric medication
Known case of systemic disorders (e.g., hypothyroidism, heart disease, kidney disease, circulatory disorders, malignancy)
Known drug allergies
Diagnosed pelvic pathology on ultra-sonography
|
|
|
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 the signs and symptoms of Premenstrual Syndrome using the Daily Record of Severity of Problems (DRSP) Assessment Tool. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in the quality of life assessed using WHOQOLBREF Scale. (subset of 26 items taken from WHQOL-100)
2. Changes in inflammatory markers associated with PMS, such as CRP and ESR levels.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/10/2026 |
| 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
|
This study is a Prospective, Randomized, Open-label, Comparative Clinical Trial designed to evaluate the efficacy of Chaturbeeja Churna with and without Rajaswala Paricharya in the management of Premenstrual Syndrome (PMS). A total of 100 women aged 18–45 years, fulfilling PMS diagnostic criteria as per the American College of Obstetricians and Gynecologists, will be randomly allocated into two groups. The intervention will be administered over three consecutive menstrual cycles. Group A will receive oral Chaturbeeja Churna along with Rajaswala Paricharya, while Group B will receive Chaturbeeja Churna alone. The primary outcome will be assessed using the Daily Record of Severity of Problems (DRSP) scale. Secondary outcomes will include assessment of quality of life using the WHOQOL-BREF scale and evaluation of inflammatory markers (CRP and ESR).Safety will be monitored by documenting adverse drug reactions throughout the study. The study aims to assess the comparative efficacy and additional benefit of Rajaswala Paricharya when used alongside Chaturbeeja Churna in PMS management. |