| CTRI Number |
CTRI/2024/05/067094 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Rasonadi Churna on Hyperandrogenism in PCOS affecting menstrual irregularities. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the efficacy of Rasonadi Churna on Hyperandrogenism in PCOS affecting menstrual irregularities. |
| 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 Rekha Chhagan Kuwar |
| Designation |
Associate Professor |
| Affiliation |
R A Podar Ayuverdic Medical College |
| Address |
OPD No.8,
Dept of Streeroga & Prasutitantra
R A Podar Ayuverdic Medical College
Dr. A B Road, Worli,
Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9405010769 |
| Fax |
|
| Email |
dr.rekhakuwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj V Gaikwad |
| Designation |
Professor |
| Affiliation |
R A Podar Ayuverdic Medical College |
| Address |
OPD No.8,
Dept of Streeroga & Prasutitantra
R A Podar Ayuverdic Medical College
Dr. A B Road, Worli,
Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj V Gaikwad |
| Designation |
Professor |
| Affiliation |
R A Podar Ayuverdic Medical College |
| Address |
OPD No.8,
Dept of Streeroga & Prasutitantra
R A Podar Ayuverdic Medical College
Dr. A B Road, Worli,
Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9822752816 |
| Fax |
|
| Email |
drmanojvgaikwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| R A Podar Ayurvedic Medical College, Worli, Mumbai - 400018 |
|
|
Primary Sponsor
|
| Name |
Dr Rekha Chhagan Kuwar |
| Address |
OPD No 8
Dept of Streeroga and Prasutitantra
R A Podar Ayuverdic Medical College
Dr A B Road Worli
Mumbai 400018 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 Rekha Chhagan Kuwar |
OPD No 8 Streeroga & Prasutitantra |
OPD No 8
Dept of Streeroga and Prasutitantra
R A Podar Ayuverdic Medical College
Dr A B Road Worli
Mumbai 400018
Mumbai
MAHARASHTRA |
9405010769
dr.rekhakuwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee R A Podar Ayurvedic Medical College, Worli, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstrual Irregularities |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasonadi Churna, Reference: Kashyap Samhita Rason Kalpadhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Go-grhita), Additional Information: In Kashyap Samhita Kalpa Sthan, in Lasunkalpa Adhyaya use of Rasonkalpa in various gynaecological disorders is well explained.
If expulsion of menstrual blood properly takes place there are least chances to prone severe medical conditions in females.
Ref-
Kashyap Samhita by Pandit Hemraj Sarma printed by Kashi Sanskrit Series 154
-Kalp Lasunkalp, Adhyay 14
-Kalp Lasunkalp, Adhyay 18 | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasonadi Churna, Reference: Kashyap Samhita Rason Kalpadhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Go-grhita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married and Unmarried patients of PCOS with Rotterdam criteria.
|
|
| ExclusionCriteria |
| Details |
Patients having
- Hypogonadotrophic hypogonadism.
- Premature ovarian failure.
- Congenital adrenal hyperplasia.
- Hyperprolactenemia.
- Thyroid abnormalities.
- Tuberculosis.
- Congenital anomalies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Rasonadi Churna in terms of irregular interval of menstrual periods. |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To study the effect of Rasonadi Churna on hyperandrogenesim.
- To study the effect of Rasonadi Churna on hyperandrogenesim and insulin resistance. |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/05/2024 |
| 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="2"
Months="0"
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
|
This study is randomized clinical controlled trial comparing the safety and efficacy of Rasonadi Churna on Hyperandrogenism in PCOC affecting Menstrual irregularities. Combination of Rasonadi Churna, Dose of 5gm BD with anupan Go-ghruta orally for 3 Months of POCS patients. Primary outcome will be evaluation of irregular interval of menstrual period during 3 Month and secondary outcome will be effect of Rasonadi Churna on Hyperandrogenism and Insulin resistance in 3 Months. |