| CTRI Number |
CTRI/2024/07/070328 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trail to evaluate the efficacy of siddhar yoga muraigal and inji chooranam II (internal) in the management of soothaga vaayu (pcos) |
|
Scientific Title of Study
|
An Open labelled Triple Armed Non Randomized Phase II Clinical Trial To Evaluate The Efficacy Of Siddhar Yoga Muraigal And Inji Chooranam II (Internal) In The Management Of Soothaga Vaayu(PCOS) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C Sowndarya |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical College and hospital palayamkottai Tirunelveli |
| Address |
2nd year
Department of siddhar yoga Maruthuvam
Government siddha medical College and hospital palayamkottai
Tirunelveli
Tamilnadu
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8012936622 |
| Fax |
|
| Email |
sowndaryasekar02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MD S |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital palayamkottai Tirunelveli |
| Address |
Department of siddhar yoga Maruthuvam
Government siddha medical College and hospital palayamkottai
Tirunelveli
Tamilnadu
India
Tirunelveli
TAMIL NADU
627007
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MD S |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical College and hospital palayamkottai Tirunelveli |
| Address |
Department of siddhar yoga Maruthuvam
Government siddha medical College and hospital palayamkottai
Tirunelveli
Tamilnadu
India
Tirunelveli
TAMIL NADU
627007
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd and Ipd Facilities And Central Library of Government Siddha Medical College And Hospital Palayamkottai Tirunelveli
Tamilnadu
India 627002 |
|
|
Primary Sponsor
|
| Name |
Dr C Sowndarya |
| Address |
2nd year
Department Of Siddhar Yoga Maruthuvam
Government Siddha Medical College And Hospital Palayamkottai
Tirunelveli
Tamilnadu
India
627002 |
| Type of Sponsor |
Other [Self] |
|
|
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 C Sowndarya |
Government Siddha Medical College And Hospital |
Department Of Siddhar Yoga Maruthuvam
Room Number 4B
Government Siddha Medical
College And Hospital
Palayamkottai
Tirunelveli
Tamilnadu
India
627002
Tirunelveli
TAMIL NADU |
8012936622
sowndaryasekar02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION 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 |
Inji chooranam II |
I gram twice a day internally for 48 days |
| Comparator Agent |
Siddhar yoga Muraigal |
Pranayamam (20-80 cycle)
Pathrasanam
Pathahastasanam
Patchimottasanam
Trikonasanam
Savasanam
Yoga therapy twice a day for 48 days |
| Intervention |
Siddhar yoga Muraigal with inji chooranam II |
Yoga therapy and Inji chooranam II 1 gram twice a day internally for 48 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient having the symptoms of irregular menstruation, oligomenorrhoea
(or) Amenorrhoea (or) Dysmenorrhoea (or) Dysfunctional uterine bleeding
Clinical evidence of Hirsutism and obesity
Hypothyroidism
USG pelvis showing polycystic ovaries (unilateral or bilateral)
Patient willing to participate in trial and signing in consent form |
|
| ExclusionCriteria |
| Details |
Hemorrhagic cyst
chocolate cyst
Endometriosis
Congenital uterine defects
hyperthyroidism
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study out come is regulation of menstruation cycle and ovulation |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Positive Impact Of Yoga In The Treatment Aspect May Be Highlighted Through This Study |
48days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
19/07/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open labelled Triple armed non-randomized phase II clinical trial to evaluate the efficacy of
SIDDHAR YOGA MURAIGAL AND INJI CHOORANAM II (Internal) in the management of SOOTHAGA VAAYU (PCOS)The study contain 3 groups and divided into Group I is siddhar yoga Muraigal.Group II is inji chooranam II and Group III is siddhar yoga Muraigal and inji chooranam II .Each group contain 20 patients and duration 48 days.The study period is 24 months will be carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002,
Tamilnadu.The outcome will be a positive impact of yoga therapy and medicine in the management of
Soothaga vaayu (PCOS).In case of any
adverse events (AE) is noticed and it will be referred to pharmacovigilence department of Further
management of patients will be given OPD patients. |