| CTRI Number |
CTRI/2018/03/012768 [Registered on: 22/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/03/2018 |
| 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 Kalingathi ennai in the patients having Polycystic Ovarian syndrome |
|
Scientific Title of Study
|
An open Non-Randomized clinical trial of Kalingathi Ennai in Soothaga Vaayu (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 Brunda S |
| 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
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8608931558 |
| Fax |
|
| Email |
drsbrinda92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanakavalli K |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna Arch Road
Nsk Nagar
Arumbakkam
Chennai
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444122865 |
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brunda S |
| 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
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
8608931558 |
| Fax |
|
| Email |
drsbrinda92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
6 Anna Arch Road
Nsk Nagar
Arumbakkam
Chennai
600106
|
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College
6 Anna Arch Road
Nsk Nagar
Arumbakkam
Chennai
600106
|
| 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 Brunda S |
Aringar Anna Government hospital of Indian Medicine |
Room no 2 siddha department
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU |
8608931558
drsbrinda92@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 |
SOOTHAGAVAAYU (POLYCYSTIC OVARIAN SYNDROME), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KALINGATHI ENNAI |
15 ml of Kalingathi ennnai is administrated once a day in early morning with warm water(30 ml).
Duration :
5 days for 3 consecutive cycles |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Married/unmarried
2 Irregular menstruation
3 Oligomenorrhoea
4 Dysmenorrhoea
5 Ovulation related infertility
6 Polycystic ovary in ultra sound
|
|
| ExclusionCriteria |
| Details |
1 Hyperthyroidism/hypothyroidism
2 Congenital uterine defects
3 Endometriosis
4 Tuberculosis of the ovary and uterus
5 Pituitary/ adrenal disorders
6 Hemorrhagic cyst
7 Chocolate cyst
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by reduction in clinical symptoms i.e, changes in the hormonal profile and changes in the size of the cyst |
5 Days for three consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
09/01/2018 |
| 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) |
Open to Recruitment |
|
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 Non randomized open clinical trial to study the safety and efficacy of Siddha trial drug Kalingathi ennai. The trial drug is given 15ml once a day for 5 days for three consecutive cycles. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Kalingathi ennai is mentioned in Sikitcha ratna deepam .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. |