| CTRI Number |
CTRI/2024/08/071940 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see the effect of Bilvadi Yog in Abnormal Uterine bleeding. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Study The Effect Of Bilvadi Yoga In Asrigdara With Special Reference To Abnormal Uterine Bleeding |
| 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 Shruti Shivaji Zendage |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti Tantra evam Stri-rog SMBT Ayurved College and Hospital Dhamangaon Igatpuri 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
07588048348 |
| Fax |
|
| Email |
shrutizendage99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Prataprao Deshmukh |
| Designation |
professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti Tantra evam Stri-rog SMBT Ayurved College and Hospital Dhamangaon Igatpuri 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9766310638 |
| Fax |
|
| Email |
drpradnya2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Shivaji Zendage |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti Tantra evam Stri-rog SMBT Ayurved College and Hospital Dhamangaon Igatpuri 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
07588048348 |
| Fax |
|
| Email |
shrutizendage99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra Evam Stri-Rog SMBT Ayurved College And Hospital,Nandi Hills,Dhamangaon,Igatpuri 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Shivaji Zendage |
| Address |
Department of Prasuti Tantra Evam Stri-Rog SMBT Ayurved College And Hospital,Nandi Hills,Dhamangaon,Igatpuri 422403 |
| Type of Sponsor |
Other [Private ayurved 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 Shruti Shivaji Zendage |
SMBT Ayurved College and Hospital |
Department of Prasuti Tantra Evam Stri-Rog SMBT Ayurved College And Hospital,Nandi Hills,Dhamangaon,Igatpuri 422403
Nashik
MAHARASHTRA |
07588048348
shrutizendage99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N939||Abnormal uterine and vaginal bleeding, 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: Bilvadi Choorna, Reference: 14. Sushrut Samhita, Uttarsthan ,chapter 40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Tandulodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthi Lodhra Choorna, Reference: 11. Yogaratnakar,Uttarardha,Streeroga adhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: - Ghruta Sharkara), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients complaining symptoms of Asrigdara such as excessive and prolonged uterine bleeding with PBAC score is greater than or equal to 150.
2. Female patients with age group 18 to 50 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Systemic Hemorrhagic Disorders.
2. Patients with Structural abnormalities like Uterine Polyps, Uterine Erosions, Uterine Fibroids, Ovarian mass, Malignancy of Uterus or Cervix, etc.
3. Postdelivery bleeding, Post MTP bleeding, Post D and C bleeding.
4. Patients with Intra Uterine Contraceptive Device.
5. Injuries to Reproductive tract.
6. Systemic disorders like, Diabetes Mellitus, Severe anemia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sign and Symptoms of Asrugdara after Giving Bilvadi Yoga |
At baseline and 7 days Reduction in Sign and Symptoms of Asrugdara after Giving Bilvadi Yoga |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| where the trial group stands in comparison with control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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
|
Prevalence rate of Asrigdara with special reference to Abnormal Uterine bleeding is 17.9 %. AUB is treated with hormonal therapy, Antifibriolytic agents, prostaglandins synthesis inhibitor and surgical management etc. in modern science which has its own side effects. Ayurvedic treatment for managing Asrigdara could be safe, non surgical , easily available and cost effective without any side effects. Bilvadi choorna has great impact on treating Asrigdara as it has Raktstambhan, vatapittahar, Shothhar and Balya properties. Clinical trial to evaluate efficacy of Bilvadi choorna would be beneficial to expand knowledge about management alternative. A clinical study of Bilvadi choorna has not yet been assessed in Asrigdara . So it will help to fill knowledge gap . Including the female patient having sign and symptoms of Asrigdara like excessive excretion of menstrual bleeding between age group of 18-50 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group). Bilvadi choorna to group A (Trial group), Shunthi lodhra with to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of choorna preparation will be followed throughout the clinical trial. Observation will be done on Oth and 0th ,8th day of 1st,2nd and 3rd menstrual period. Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn, and thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out. |