| CTRI Number |
CTRI/2024/12/078529 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| 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
|
Oral Intake Of Yashtimadhu Sita Churna With Tandulodak In The Management Of Raktapradar |
|
Scientific Title of Study
|
Open randomized control clinical trial of yashtimadhu sita churna with tandulodak in raktapradar with special reference to 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 Sharayu 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 Tal Walwa Dist Sangli 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9623070730 |
| Fax |
|
| Email |
rautsharayu0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Associate 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 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Associate 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 416301
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 Tal Walwa Dist sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Sharayu Laxmanrao Raut |
| Address |
Department Of Strirog And Prasuti Tantra Of Dhanwantari Hospital Of Hon.Shri Annasaheb Dange Ayurved Medical College ,Ashta Tal Walwa Dist Sangli 416301 india |
| 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 Sharayu Raut |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanwantari Ayurved Hospital Ashta |
OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanwantari Hospital Ashta Tal walwa Dist Sangli
Sangli
MAHARASHTRA |
09623070730
rautsharayu0@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 Ashta Tal Walwa Dist Sangli Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular 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: Yahtimadhu Sita, Reference: Bhavprakash Madhyamkhand, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Tandulodak), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Combined Oral Contraceptive Pill Tab Ovral-L, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients fulfilling Diagnostic criteria Patient Having Heavy menstruation with Duration of Bleeding More Than 7 days or Amount of Bleeding More Than 80ml or both at least Two Consecutive cycle.
Patients having regular menstrual cycle.
Patients having uterine fibroid size less than or equal to 4cm and fibroid measuring 4 cm only 3 fibroid will be included.Patient having HB More Than 7 gm % Included |
|
| ExclusionCriteria |
| Details |
1 Patient Having Congenital Anomaly Of Reprductive System
2 Pregnant Women
3 Patients With Post Menopausal Bleeding And Intra Uterine Devices
4 Known Case Of DM Malignancy Coagulopathy
5 Uncontrolled HTN |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yashtimadhu Sita Churna With Tadulodak Is Effective In The Management Of Raktapradar |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Combined Oral Contraceptive Pills(Tab Ovral-L) Is Effective In The Management Of Raktapradar |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
28/12/2024 |
| 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
|
Female reproductive system has a great importance and any disease related to this system will seriously affect womens health and happiness and proves to be great discomfort.now a day due to changing life style and food habits complain of the excessive uterine bleeding is increasing day by day .many side effects have been observed because of modern medication and hysterectomy leading to hormonal imbalance and psychological upset in young fertile women.so keeping mind i took Ayurvedic drug Yahtimadhu sita churna with tandulodak from 1st day of 1st menstural cycle of treatment and will be continued for consecutive 90 days which is non hormonal and safe that could provide effective treatment on raktapradar. |