| CTRI Number |
CTRI/2023/05/052474 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Dhataki Pushpa Churna in Heavy Menstrual Bleeding |
|
Scientific Title of Study
|
Efficacy of Dhataki Pushpa Churna in the Disintegration of Pathogenesis of Asrugdara (Heavy Menstrual Bleeding) - A Single arm clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renu Yadav |
| Designation |
PG Scholar |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi |
| Address |
Room no 143, PG Department of Rog Nidan Evum Vikruti Vigyan, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi
South West
DELHI
110073
India |
| Phone |
8510985411 |
| Fax |
|
| Email |
renuyadav2736@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditaya Nath Tewari |
| Designation |
Associate Professor |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi
South West
DELHI
110073
India |
| Phone |
9711434847 |
| Fax |
|
| Email |
dr.aditaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditaya Nath Tewari |
| Designation |
Associate Professor |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi |
| Address |
PG Department of Rog Nidan Evum Vikruti Vigyan, Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi
South West
DELHI
110073
India |
| Phone |
9711434847 |
| Fax |
|
| Email |
dr.aditaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-110073 |
|
|
Primary Sponsor
|
| Name |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi-110073 |
| 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 Renu Yadav |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Room no 143, PG Department of Rog Nidan Evum Vikruti Vigyan,Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar New Delhi-110073
South West
DELHI |
8510985411
renuyadav2736@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhataki Pushpa Churna, Reference: YogRatnakar Pradar Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 02 Months, anupAna/sahapAna: Yes(details: -Tandulodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Duration of menstrual flow >7days
Irregular and excessive Menstrual bleeding
Reduction in the inter menstrual cycle period
Patient with heavy menstrual bleeding since two consecutive cycles atleast |
|
| ExclusionCriteria |
| Details |
Patients with any co-morbities.
Coagulative Disorders
Patient with any other organic lesion i.e. uterine fibroid, ovarian cyst, carcinoma etc.
IUCD Pregnancy
Hb% < 8mg/dl |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Findings of the study will be beneficial in the clinical management of Asrugdara (Heavy
menstrual bleeding) by establishing the efficacy of dhataki pushpa churna . |
Two Consecutive Cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will provide cost effective, safe drug with lesser side effects
|
Two Consecutive Cycles |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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 4 |
|
Date of First Enrollment (India)
|
25/05/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Any abnormality in rutuchakra (menstrual rhythem) which leads to excessive and irregular uterine bleeding is known as Asrugdara. Heavy menstrual bleeding is the term for menstrual periods with abnormally heavy ( >80 ml) or prolonged bleeding (>7 days) that interferes with the women’s physical, emotional, social and maternal quality of life.
The present study is aimed to find out the efficacy of dhataki pushpa churna along with tandulodaka in asrugdara.
Study type is Interventional and Study design is single arm clinical trial with sample size of 55 patients.
Dhataki Pushpa Churna will be given in the dose of 5gm with Tandulodaka , Twice Daily, Before meal (Apan Kala) for two consecutive cycles.
This study is expected to be beneficial in clinical management of Asrugdara ( Heavy Menstrual Bleeding) |