| CTRI Number |
CTRI/2022/01/039331 [Registered on: 11/01/2022] Trial Registered Prospectively |
| Last Modified On: |
11/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Streerog & Prasuti] |
| Study Design |
Other |
|
Public Title of Study
|
To study Shatapushpa Churna effects in animal study & in patients of Polycystic Ovarian Syndrome. |
|
Scientific Title of Study
|
In vitro and controlled clinical study of shatapushpa churna in polycystic ovarian syndrome
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Sandeep Gaikwad |
| Designation |
Ph D Scholar |
| Affiliation |
R A Podar Ayurved Medical College |
| Address |
Mumbai
Streerog & Prasutitantra Dept
Dr A B Road
Worli Mum 400018
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9699825626 |
| Fax |
|
| Email |
drrutujasg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha J Dewaikar |
| Designation |
HOD and PhD Guide |
| Affiliation |
R A Podar Ayurved Medical College |
| Address |
Worli Mumbai
Streerog & Prasutitantra Dept
Dr A B Road
Worli Mum 400018
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9869079197 |
| Fax |
|
| Email |
drdewaikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Sandeep Gaikwad |
| Designation |
Ph D Scholar |
| Affiliation |
R A Podar Ayurved Medical College |
| Address |
Mumbai
Streerog & Prasutitantra Dept
Dr A B Road
Worli Mum 400018
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9699825626 |
| Fax |
|
| Email |
drrutujasg@gmail.com |
|
|
Source of Monetary or Material Support
|
| R A Podar Ayurved Medical College Worli mumbai 400018 |
|
|
Primary Sponsor
|
| Name |
DrRutuja SGaikwad |
| Address |
Room No 11 12
Building No 06
112 BMC Quarters
J B Temkar Marg
Worli Mumbai |
| Type of Sponsor |
Other [Myself] |
|
|
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 Rutuja Gaikwad |
R.A.Podar Ayurved College |
Streerog and Prasuti Tantra Dept, Hospital Building, OPD No 2, Dr.Annie Besant Road, Worli,Mumbai-400018
Mumbai
MAHARASHTRA |
9699825626
drrutujasg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| GOVT AYURVED MAHAVIDYALAYA, VAZIRABAD,NANDED |
Approved |
| R A PODAR MEDICAL COLLEGE (AYU) WORLI, MUM 18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: Polycystic Ovarion Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
METFORMIN |
METFORMIN 850 MG SR
once a day |
| Intervention |
Shatapushpa Churna 10 gms, Orally |
Shatapushpa dry seeds are purchased from the available source in market.Its fine powder is prepared as per the standard norms mentioned in Ayurvedic Text.10gm of churna is administered orally early morning empty stomach with Goghrut to each subject with PCOS.Standardisation and authentification of the drug is done from ALARSIN Pharmaceuticals,Mumbai. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
-All married & unmarried cases
-USG with polycystic ovaries showing multiple small peripheral follicles(>12 follicles)in each ovary measuring 2-9mm in diameter and/or increased ovarian volume >10mm.
-All cases of PCOS having amenorrhoea/oligomenorrhoea.
-PCOS patients having signs of hyperandrogenism |
|
| ExclusionCriteria |
| Details |
-Amenorrhoea of menopause
-Patients of PCOS with DM/HTN/Hypothyroidism/Hyperthyroidism/TB/HIV/HbSAg/VDRL
-Cases of prgnancy,cervical tumor/polyp, uterine fibroid
-known cases of systemic illness like asthma,cardiovascular and renal diseases,malignancy, Salpingo oophoritis, Cervical erosion, anatomical defective genitalia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To observe the histopathological changes & steroidogenic enzyme activity in ovary in the Laterozole induced PCOS rat animal after administration of Shatapushpa churna
-To evaluate the ovulatory effects of Shatapushpa churna in Latrazole induced PCOS in rat animal
-To study the clinical action of Shatapushpa Churna in PCOS by assessing ovulatory effects ,reduction in ovarion volume and status of menstruation. |
9 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To evaluate the effects of Shatapushpa churna in PCOS by assessing the changes in biochemical markers like FSH LH E2 TESTOSTERON DHEAS GTT SERUM LIPID PROFILE SERUM INSULIN LEVEL
-To assess the effect of Shatapushpa churna in Achanthosis Nigrans Hirsutism Acne |
9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - in
data will be saved in google drive & can be made available in 3 years after obtaining phd for approved study by ethics committee.
- For how long will this data be available start date provided 01-01-2022 and end date provided 30-09-2022?
Response (Others) - 3 years
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title of the study is IN VITRO & CONTROLLED CLINICAL STUDY OF SHATAPUSHPA CHURNA IN POLYCYSTIC OVARIAN SYNDROME. This study is animal experimental study & open randomised controlled clinical study. Animal study will be done at NIRRH ICMR Parel,Mumbai & will be performed on total 48 rats (6 groups having 8 rats each). Selection of PCOS cases and confirmation of exclusion and inclusion criteria is done with proper investigations required done. Shatapushpa dry seeds are purchased from the available source in market.Its fine powder is prepared as per the standard norms mentioned in Ayurvedic Text.10gm of churna is administered orally early morning empty stomach with Goghrut to each subject with PCOS.Standardisation and authentification of the drug is done from ALARSIN Pharmaceuticals,Mumbai.Tablet Metformin sustained release 850mg is given to the subjects in control group.Total 100 sample size is taken for the study. Data collection and results will be recorded. Statistical calculations will be done as per the suitable guidelines.Conclusion will be drawn. |