| CTRI Number |
CTRI/2025/11/097545 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nagaradi kashaya and Manjishtha kashaya in Primary Dysmenorrhoea |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of Nagaradi Kashaya and Manjishtha Kashaya in the management of Kashtartava with special reference 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 POOJA BIND |
| Designation |
M.S. Scholar |
| Affiliation |
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi |
| Address |
Department of Prasuti Tantra and Stree Roga
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9696007884 |
| Fax |
|
| Email |
pbind545@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHASHI SINGH |
| Designation |
PROFESSOR & HOD |
| Affiliation |
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi |
| Address |
Department of Prasuti Tantra and Stree Roga
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
945168056 |
| Fax |
|
| Email |
shashi.aymc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANJANA SAXENA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi |
| Address |
Department of Prasuti Tantra and Stree Roga
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839041045 |
| Fax |
|
| Email |
dranjana.saxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi ,Uttar Pradesh 221002
|
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and Hospital |
| Address |
Department of Prasuti Tantra and Stree Roga
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi ,Uttar Pradesh 221002 |
| 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 POOJA BIND |
Government PG Ayurveda College and Hospital |
OPD no. 36 and OPD no. 1
Department of Prasuti Tantra and Stree Roga
Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH |
9696007884
pbind545@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi,U.P Mahayogi Guru Gorakhnath Ayush University, Gorakhpur,U.P |
Approved |
| Institutional ethics committee Government PG Ayurveda College and Hospital, Chaukaghat, Varanasi,U.P Mahayogi Guru Gorakhnath Ayush University, Gorakhpur,U.P |
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: Ngaradi kashaya, Reference: Harit samhita chi. 48/13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -during menses dugdha and after menses dadhi and gud), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Manjishtha Kashaya, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient willing and able to participate in study.
2.Female patients of age 15 to 25 years.
3.Patient suffering from Primary dysmenorrhoea with average amount of
menstrual flow in regular menstrual cycle.
4. Patient suffering from Kashtartava for more than 2 consecutive cycles. |
|
| ExclusionCriteria |
| Details |
1. Patient not willing for trial.
2. Female patients below 15 years and above 25 years of age.
3. Patients with any identifiable pelvic pathology and menstrual
irregularities.
4. Patients using IUD/oral contraceptive pills.
5. Patients with chronic general illness like TB, HTN, DM, etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see the effect of "NAGARADI KASHAYA" in reducing pain during
menses. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Provide releif in nausea,breast tenderness and loss of appetite. |
3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
INTERVENTIONAL STUDYPatients having classical features of Kashtartava (primary dysmenorrhoea) attending OPD and IPD of PRASUTI TANTRA AND STRI ROGA departments of Govt. Ayurvedic PG College and Hospital Varanasi will be selected randomly for this clinical study. The patient will also select from special camps organized time to time by the PRASUTI TANTRA AND STRI ROGA departments. Group-A-30 patients, who were given trial drugs "NAGARADI KASHAYA" (40 ml) with anupan of dadhi (curd) and gud (jaggery) for 5–7 days (during menstruation). After that, with anupaan of dugdha (milk) for 10 days. Group-B-30 patients, who were given "MANJISHTA KASHAYA" 40 ml. with the same anupan. Duration of trial: 3 months. Treatment will be done after cessation of menstruation. Treatment is continued for a period of 3 months. Patients were followed twice regularly at the end of menstrual flow and after 15 days for 3 months. |