| CTRI Number |
CTRI/2023/09/057536 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy Of Dhatryadi Churna In Excessive Menstrual Bleeding Due To Uterine Fibroid |
|
Scientific Title of Study
|
Efficacy of dhatryadi churna in asrugadara (menorrhagia) due to uterine fibroid |
| 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 Rupali Babasaheb Raut |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor Dhanwantari Ayurveda Hospital Ashta Tak Walwa Dist Sangli MAHARASHTRA 416301 India Sangali
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor Dhanwantari Ayurved Hospital Tal Walwa Dist Sangli MAHARASHTRA 416301 India Sangali
Sangli
MAHARASHTRA
416301
India |
| Phone |
8329838729 |
| Fax |
|
| Email |
rupalibraut1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli MAHARASHTRA Sangli
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli MAHARASHTRA Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli MAHARASHTRA Sangli
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli MAHARASHTRA Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Rupali Babasaheb Raut |
| Address |
OPD no 06 Strirog And Prasuti Tantra OPD Ground Floor Walwa Dist Sangli MAHARASHTRA 416301 India Sangli |
| 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 Rupali Babasaheb Raut |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanwantari Ayurved Hospital Ashta |
OPD no 6 strirog And Prasuti Tantra OPD Ground Floor Dhanvanatari Hospital Ashta Tal Walwa Dist sangli MAHARASHTRA
Sangli
MAHARASHTRA |
8329838729
rupalibraut1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center AshtaInstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatryadi Churna, Reference: Rasendrasarsangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient fufilling diagnostic criteria patient having heavy menstruation with duration of bleeding>7days Or Amount of bleeding >80 ml Or both at least consecutive 2 cycles fibroid size less than Or equal to 4cm will be included fibroid measuring 4cm only 3 fibroid will be included |
|
| ExclusionCriteria |
| Details |
Pregnant women patient with iucd Or oc pills patient suffering from anaemia hb less than 7gm% |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of dhatryadi churna on menorrhagia |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of Dhatryadi Churna on Uterine Fibroid To Review The Ayurvedic Concept Of Asrugadara According To Different Acharyas To Review The Conceprt Of Menorrhagia To Review The Concept Of Uterine Fibroid To Access Properties positive effect & untoward effect of dhatryadi churna Regarding Asrugdara ( menorrhagia) Due to Fibroid To Observe Recuurence of Disease After Completion of treatment for 3 months telephonic Follow Up Only For Subjective Criteria |
90 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
20/09/2023 |
| 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="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
|
Menorrhagia due to uterine fibroid is comman menstrual disorder prevalance rate of menorrhagia due to uterine fibroid 37.65% current study is single arm study in menorrhagia due to uterine fibroid drug dhatryadi churna contain 3 constiuents Amalaki Haritaki and Rasanjana drug dhatryadi churna dose 2gm bd for 3months follow up |