| CTRI Number |
CTRI/2021/11/038124 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effect of the drug Soothaga Chooranam in patients having S Poly Cystic Ovarian Syndrome (Soothaga Vaayu) |
|
Scientific Title of Study
|
Phase II Non -Randomized Open Clinical Evaluation of Siddha Medicine Soothaga Chooranam For Soothaga vaayu (Poly Cystic 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 Boomathi S |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9095909539 |
| Fax |
|
| Email |
boomathisozhanambi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chithra S M |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
|
| Email |
chittu758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chithra S M |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 Tamil Nadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
|
| Email |
chittu758@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Anna Arch Road Arumbakkam Chennai 600106 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College Anna Arch Road Arumbakkam Chennai 600106 Tamil Nadu |
| 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 Boomathi S |
Arignar Anna Government Hospital of Indian Medicine |
Op no S1 Department of PG Maruthuvam Government Siddha Medical College Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
9095909539
boomathisozhanambi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
Soothaga Chooranam |
1250-1500 mg of Soothaga Chooranam with administered twice a day with Warm water for 48 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Unmarried and married women
Married women with primary infertility
H/o Amenorrhea
H/o Irregular menstruation
H/o Ovulation related infertility
H/o Oligomenorrhoea
H/o Poly cystic ovary in ultra sound (unilateral/ bilateral) |
|
| ExclusionCriteria |
| Details |
H/o Hyperthyroidism /hypothyroidism
H/oCongenital uterine defects
H/o Pituitary/adrenal disorders
H/o Hemorrhagic cyst
H/o Chocolate cyst
H/oAny serious systemic illness
H/o Tuberculosis of the ovary and uterus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by regulation of menstrual cycle hormonal profile and ovulation Reduction/disappearance in the size and number of cyst in ovary |
It is mainly assessed by regulation of menstrual cycle hormonal profile and ovulation Reduction/disappearance in the size and number of cyst in ovary |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
48 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/11/2021 |
| 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 Recruiting |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single non randomized open clinical trial to study the safety and efficacy of the Soothaga Chooranam. The trial drug is given 1250-1500 mg twice a day for 48 days.Clinical trial is conducted after conducting pre clinical toxicity study. The trial drug Soothaga Chooranam is mentioned in Sarabendirar Siddha Maruthuva Sudar. During the trial all the study related date will be recorded and documented. After the completion of trial all the data will be analysed statistically. |