| CTRI Number |
CTRI/2024/06/069322 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to see the effect of Yashti and Sita yoga in Raktapradara( Heavy Menstrual Bleeding) |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Yasthi and Sita yoga in Raktapradara |
| 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 Ashwini N Fulari |
| Designation |
MS Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Opd no 2 and IPD ,Stree rog and Prasuti tantra department,Dr . D. Y. Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pune ,Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8123196541 |
| Fax |
|
| Email |
ash.fulari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Barathe |
| Designation |
Professor |
| Affiliation |
Dr. D.Y. Patil College of Ayurved and Research Centre,Pimpri |
| Address |
Opd no 2 and IPD ,Stree rog and Prasuti tantra department,Dr . D. Y. Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pune ,Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8484048002 |
| Fax |
|
| Email |
rahul.barathe@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini N Fulari |
| Designation |
MS Scholar |
| Affiliation |
Dr. D.Y. Patil College of Ayurved and Research Centre,Pimpri |
| Address |
Opd no 2 and IPD ,Stree rog and Prasuti tantra department,Dr . D. Y. Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pune ,Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
8123196541 |
| Fax |
|
| Email |
ash.fulari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune Maharashtra India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini N Fulari |
| Address |
Dr.D.Y. Patil Collge of Ayurved and Research Centre ,Sant Tukaram Nagar,Pimpri,Pune,Maharashtra,411018 |
| 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 Ashwini N Fulari |
Dr D.Y.Patil Collge of Ayurved and Research Centre ,Sant Tukara Nagar,Pimpri,,Pune |
Opd and IPD,Stree rog and Prasuti tantra Department,Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune, Maharashtra,411018
Pune
MAHARASHTRA |
8123196541
ash.fulari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA and RC INSTITUTIONAL ETHICS COMMITTEE |
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: Yashti and Sita yoga, Reference: Bhavprakash Nighantu Madhyam 68/12, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -tandulodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients with prolonged menstrual bleeding,
patients with excessive menstrual bleeding
patients with intermenstrual bleeding
Age group of 18-55 years of age
|
|
| ExclusionCriteria |
| Details |
Patients with fibroid,polyp,malignancy,tuberculosis,diabetes,hypertension,intrauterine devices,coagulation disorders,
Hb less than 8gm%,
Veneral disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Yasthi and Sita yoga in Raktapradara in stopping the heavy menstrual bleeding by the given drug intervention by assessing the number of pads used |
the effect will be assessed after 10 days of drug intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the other effects of yasthi & sita yoga in Raktapradara in 2 consecutive menstrual cycles in stoppage of the heavy menstrual bleeding by assessing the number of pads used |
the outcome is assessed for 2 consecutive menstrual cycles |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2024 |
| 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)
|
Other (Terminated) |
| 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
|
This is a Single Arm Clinical study. The aim of this study to evaluate the efficacy of asthi and sita yoga in Raktapradara. Total of 40 patients will be enrolled and 6gm of Yashti and sita churna along with tandulodaka will be given twice daily for 10 days. The age group taken for this study includes18-55 yrs The follow up will be taken for next two consecutive cycles. Subjective and Objective Criteria will be studied. |