| CTRI Number |
CTRI/2025/03/083378 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| 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 Bharangi Nagar Churna with rice soaked water in heavy bleeding along with increased duration of menses in age group of 13 to 19 years. |
|
Scientific Title of Study
|
A RANDOMIZED OPEN CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY OF BHARANGI NAGAR CHURNA WITH TANDULODAK IN TARUNI ASRUGDAR W.S.R. TO PUBERTY MENORRHAGIA |
| 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 Snehal Laxman Dongare |
| Designation |
PG Student of Prasutitantra avum strirog |
| Affiliation |
Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur |
| Address |
Department of Prasutitantra avum strirog OPD no 8 and15 Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308079218 |
| Fax |
|
| Email |
dongaresnehal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Mule |
| Designation |
Guide and Associate professor |
| Affiliation |
Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur |
| Address |
Department of Prasutitantra avum strirog OPD no 8 and 15 Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
kvt126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Laxman Dongare |
| Designation |
PG Student of Prasutitantra avum strirog |
| Affiliation |
Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur |
| Address |
Department of Prasutitantra avum strirog OPD no 8 and 15 Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308079218 |
| Fax |
|
| Email |
dongaresnehal1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Snehal Laxman Dongare |
| Address |
Department of Prasutitantra avum strirog OPD no 8 and 15 Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli District Kolhapur |
| 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 Snehal Laxman Dongare |
Yashwant Ayurvedic College Postgraduate Training and Research Centre Kodoli |
OPD no 8 and 15 of
Prasuti Tantra avum strirog department
Yashwant Ayurvedic Medical College PGT and RC Kodoli, District Kolhapur
Kolhapur
MAHARASHTRA |
8308079218
dongaresnehal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: ARTAVAVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bharangi Nagar Churna , Reference: Bhavprakash Chikitsa,strirogadhikar adhyay 68/13,page no 755, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Tandulodak ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagkeshar Churna , Reference: Bhav Mishra,Bhav Prakash Nighantu,Karpuradi varg shlok 69 to 71 page no 78, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1 Age 13 to 19 years unmarried girls
2 Patients with complaints of excessive bleeding per vagina during
menstruation either in amount or duration
3 Polymenorrhagia
4 Patient with Hb 9gper dl or more than 9g per dl |
|
| ExclusionCriteria |
| Details |
1Known case of Endocrinal Disorder like Hypo or Hyperthyroidism PCOS
2 Known case of Bleeding Dyscrasias
3 Known case of Structural Abnormality in Genital Organ
4Known case of systemic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Bharangi Nagar churna with tandulodak in Taruni
Asrugdar W.S.R. to Puberty Menorrhagia. |
1st and 5th day of every cycle and after cessation of menses of every cycle for 3 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To reduce duration & amount of bleeding.
2. To assess improvement by parameters like PBAC.
3. To achieve the control on excessive bleeding.
4. To study the etio-pathology of asrugdar in detail according to Ayurvedic &
puberty menorrhagia details according to modern text.
5. To achieve the out-come of study in 90 days (3 Menstrual cycles). |
90 days |
|
|
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)
|
30/03/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dongaresnehal1998@gmail.com].
- For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is randomised open controlled clinical trial to study the efficacy of bharangi nagar churna with tandulodak in taruni asrugdar in pubertal age group conducted at OPD no 8 and 15 of Yashwant dharmarth rugnalaya kodoli kolhapur. The result will be assess after 90 days of study. |