| CTRI Number |
CTRI/2019/08/020859 [Registered on: 23/08/2019] Trial Registered Prospectively |
| Last Modified On: |
19/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to find out the efficacy of the Siddha drug Sathakuppai Chooranam in patients with Polycystic Ovarian Syndrome
|
|
Scientific Title of Study
|
Phase II Non-randomized open clinical evaluation of siddha drug Sathakuppai chooranam for Soothaga vaayu(PCOS) in women of age between 15 and 35 years attending OPD at AAGHIM attached with GSMC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathya Priyanka P M |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
7708595104 |
| Fax |
|
| Email |
pmsathyapriyanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Menaka R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathya Priyanka PM |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
7708595104 |
| Fax |
|
| Email |
pmsathyapriyanka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
| Type of Sponsor |
Government medical college |
|
|
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 Sathya Priyanka P M |
Arignar Anna Government Hospital of Indian Medicine |
Room no 2 Siddha Department 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu
Chennai
TAMIL NADU |
7708595104
pmsathyapriyanka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sathakuppai chooranam |
5 grams of Sathakuppai chooranam is administered twice a day for 90 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Female between 15 and 35 years
Unmarried and married women
Married women with primary infertility
Amenorrhoea
Irregular menstruation
Ovulation related infertility
Oligomenorrhoea
Polycystic ovary in ultra sound(unilateral/bilateral)
|
|
| ExclusionCriteria |
| Details |
H/O Hyperthyroidism/Hypothyroidism
H/O Congenital uterine defects
H/O Pituitary/Adrenal disorders
H/O Hemorrhagic cyst
H/O Chocolate cyst
H/O Any serious systemic illness
H/O Tuberculosis of the ovary and uterus
Will be excluded clinically or based on the available medical reports |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Regulation of menstrual cycle
Regulation of hormonal profile
Regulation of ovulation
Disappearance/reduction in the size or number of the cyst |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
26/08/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single group Non randomized open clinical trial to study the safety and therapeutic efficacy of Siddha trial drug Sathakuppai chooranam.The trial drug is given 5grams twice a day for 90 days.Clinical trial is conducted after Pre clinical toxicity study.The trial drug Sathakuppai chooranam is mentioned in Anubogavythia Bramaragasiyam part 2.During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analyzed statistically |