| CTRI Number |
CTRI/2024/12/077965 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Oral administration Of Tab Kanchanar In Patient With Raktapradar |
|
Scientific Title of Study
|
RANDOMIZED UNCONTROL CLINICAL TRIAL OF EFFICACY OF TAB KANCHANAR IN RAKTAPRADAR (MENORRHAGIA) DUE TO 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 Kanchan Madhav Rote |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta |
| Address |
OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital, Ashta Tal Walwa Dist Sangli
OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital, Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7745094129 |
| Fax |
|
| Email |
kanchanrote14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta Tal Walwa Dist 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 Medica College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medica College Post Graduate and Research Center Ashta Tal Walwa Dist 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 Tal Walwa Dist Sangli Maharashtra India 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Kanchan Madhav Rote |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist 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 Kanchan Madhav Rote |
Hon Shri Annasaheb Dange ayurved Medical College Post Graduate and Research Center Ashta |
Hon Shri Annasaheb Dange ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Maharashtra India 416301
Sangli
MAHARASHTRA |
7745094129
kanchanrote14@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 centre Ashta institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanchanar , Reference: Acharya Mishra Brahmashankar ,Bhavaprakasha nighantu Guduchyadi varga, shlok no-101-104, p.336-337, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient willing to give informed written consent.
2.Patient having heavy menstrual bleeding with duration of
bleeding more than 7 days or amount of bleeding more than 80ml or both at least 2
consecutive cycles. |
|
| ExclusionCriteria |
| Details |
1. Patient having fibroid size more than 4cm.
2. Post menopausal bleeding.
3. Hb less than 7g/dL.
4. Patient using IUCD.
5. Pregnant women.
6. Patient having congenital anomalies. |
|
|
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 Tab Kanchanar in Raktapradar. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review Ayurvedic Concept of Raraktapradar according to
different Acharyas.
To review concept of uterine fibroid .
To assess any untoward effects of Tab Kanchanar. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
30/12/2024 |
| 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 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
|
In ayurveda the term asrugdara called pradiran which means excessive menstrual blood loss and prolonged menstrual bleeding. It is not directly mentioned as disease but given as symptom of gynaecological disorder. Asrugdara is also known as Raktapradar as mentioned in Charak samhita. In modern science Raktapradar can be correlated with menorrhagia. Menorrhagia is defined as a cyclic menstrual bleeding at normal intervals which is excessive bleeding means > 80ml or prolonged menstruation means >7 days or both. Any uterine bleeding outside the normal volume, duration, regularity or frequency is considered as Abnormal uterine bleeding. Nowadays various treatment modalities like hormonal therapy, antiprostaglandins, antifibrinolytic agents are available to treat menorrhagia. But hormonal therapy has many side effects and once you stop the treatment relapse is there after sometime. There is no definite treatment available for uterine fibroids in modern science. As mentioned in samhitas, Raktapradar is type of adhog raktapitta in which pitta and vata dosha, rasa and rakta dhatu vikruti found as heavy blood loss which is an emergency need to treat as early as possible. So raktasthambhan chikitsa is to be done to stop the blood loss. Rakta Kanchanar is kashay, sheet, sangrahi, raktapittaghna hence is selected for this study.
|