| CTRI Number |
CTRI/2017/03/008064 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
10/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of siddha medicine in the treatment of sinaipaineerkatti PCOS |
|
Scientific Title of Study
|
Effectiveness of MalaivembathyThylam and Arumuga Chenduram in the treatment of 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 S IYSWARYA |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9626015001 |
| Fax |
|
| Email |
iysbsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S SIVAKKUMAR |
| Designation |
LECTURER |
| Affiliation |
National Institute of Siddha |
| Address |
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962528338 |
| Fax |
|
| Email |
ssknis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Visweswaran |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
DEPARTMENT OF GUNAPADAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962542755 |
| Fax |
|
| Email |
svisu11@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
TAMBARAM SANATORIUM
CHENNAI 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S IYSWARYA |
NATIONAL INSTITUTE OF SIDDHA |
ROOM NO 2
DEPARTMENT OF GUNAPADAM NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNA 47
Chennai
TAMIL NADU |
9626015001
iysbsms@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 |
patients with the complaints of PCOS confirmed by USG , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
patient with complaints of PCOS (amenorrhoea, dysmenorrhoea,infertility,obesity) confirmed by USG.
Patient willing to undergo ultrasound abdomen and routine blood investigation |
|
| ExclusionCriteria |
| Details |
chronic kidney disease
pregnancy and lactation
HIV and Hepatitis
presence of any serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correct the ovulatory defect with normal USG report
Reduction in size of the ovarian cyst |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
positive pregnancy test
Reduction in body weight
To observe the changes in the lipid profile value |
6 months |
|
|
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 1 |
|
Date of First Enrollment (India)
|
20/03/2017 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Many diseases are emerging as a trend of lifestyle modifications due to stress, sedentary lifestyle and food habits. One among them and most important in reproductive age group of female is Soothaga Vaayu. The symptoms of soothaga vaayu are amenorrhoea, oligomenorrhoea followed by menorrhagia, dysmenorrhoea, infertility, missed abortion, low back ache, constipation and obesity. It may be correlated with Polycystic ovarian syndrome (PCOS) of modern science. Siddhars mentioned many formulations in treating uterine diseases. Among them, Malaivembathy Thylam and Arumuga Chenduram mentioned in Siddha Vaithiya Thirattu, indicated for uterine diseases.
|