| CTRI Number |
CTRI/2020/09/027580 [Registered on: 03/09/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of the Siddha medicine in patients having Poly cystic ovarian syndrome (PCOS) |
|
Scientific Title of Study
|
Phase II Non randomized open clinical evaluation of Siddha medicine Thumattikkai Mezhugu for Soothaga Vaayu (PCOS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abisha R |
| 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 -106 Tamilnadu India
Post Graduate Department of General Medicine Government Siddha Medical college 6 Anna arch road NSK nagar Arumbakkam Chennai -106 Tamilnadu India
Chennai
TAMIL NADU
600106
India |
| Phone |
8825794303 |
| Fax |
|
| Email |
abishahepzhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjeevanam G |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical college |
| Address |
Government Siddha Medical college 6 Anna arch road NSK nagar Arumbakkam Chennai -106 Tamilnadu India
6 Anna arch road NSK nagar Arumbakkam Chennai - 106 Tamilnadu India
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abisha R |
| 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 -106 Tamilnadu India
Post Graduate Department of General Medicine Government Siddha Medical college 6 Anna arch road NSK nagar Arumbakkam Chennai -106 Tamilnadu India
Chennai
TAMIL NADU
600106
India |
| Phone |
8825794303 |
| Fax |
|
| Email |
abishahepzhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical college, Arumbakkam Chennai - 106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical college |
| Address |
Government Siddha Medical college 6 Anna arch road NSK nagar Arumbakkam Chennai - 106 Tamilnadu India |
| 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 Abisha R |
Arignar Anna Government Hospital of Indian Medicine |
Room no S1 Siddha department 6 Anna arch road NSK nagar Arumbakkam Chennai - 106
Chennai
TAMIL NADU |
8825794303
abishahepzhi@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 |
THUMATTIKKAI MEZHUGU |
130 mg of Thumattikkai mezhugu is administered once in a day at morning with palm jaggery for 3 days during menstrual cycle. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
subjects within 15 - 35 years
Both Unmarried and married women
Amenorrhoea
Irregular menstruation
Oligomenorrhoea
Polycystic ovary in ultra sound ( unilateral/
bilateral) |
|
| ExclusionCriteria |
| Details |
H/O Hypothyroidism/ Hyperthyroidism
H/O Pituitary/ adrenal disorders
H/O Hemorrhagic cyst
H/O Chocolate cyst
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 |
| Primary outcome is mainly assessed by regulation of menstrual cycle regulation of ovulation disappearance / reduction in the size or number of the cyst |
3 days (3 consecutive cycles) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the hormonal levels reduction in size of cyst before and after treatment |
3 days ( 3 consecutive cycles) |
|
|
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)
|
14/09/2020 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a single Non randomized open clinical trial to study the safety and efficacy of Siddha medicine Thumattikkai mezhugu. The medicine is given 130mg once in a morning during menstrual cycle for 3days (3 consecutive cycles). Clinical trail is conducted after conducting Pre clinical toxicity study. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |