| CTRI Number |
CTRI/2024/06/069265 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Evaluation of Siddha Medicine Soosika Chooranam for Soothaga Vaayu (PCOD) |
|
Scientific Title of Study
|
Single Centric Non Randomized Open Clinical trial Phase II in Soothaga Vaayu (PCOD) with Siddha Medicine Soosika Chooranam among patients attending OPD at Government Siddha Medical College Hospital, Chennai. |
| 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 G Sanjana |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College,Chennai. |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
8939311792 |
| Fax |
|
| Email |
sanjugopi1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Chithra |
| Designation |
Lecturer, Department of PG Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College,Chen |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U Chithra |
| Designation |
Lecturer, Department of PG Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College,Chen |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, No-6, Anna Arch Road,Arumbakkam, Chennai - 600106. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College, Chennai |
| Address |
No-6, Anna Arch Road, 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 G Sanjana |
Government Siddha Medical College, Chennai. |
Department of PG Pothu Maruthuvam, Room No. S1, Government Siddha Medical College Hospital, Arumbakkam, Chennai 600106.
Chennai
TAMIL NADU |
8939311792
sanjugopi1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Arumbakkam, Chennai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Soosika Chooranam |
The medicine will be given 2gms twice a day for 40 days with Adjuvants(Paccharisi Kazhuneer - 1-10 days,Muthakasu kudineer
-11 - 20 days,
Puliyatha pasumor
-21 - 30 davs
Elavenneer
- 31 - 40 days.
Total : 40 days (For 3 consecutive menstrual cycles) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
a.Female aged between 15-45 years (24).
b. Based upon the presence of any two of the following Rotterdam criteria
1.Oligo / Anovulation
2.Hyperandrogenism (Clinical/Biochemical)
3.Polycystic ovaries (unilateral/bilateral)
c. Seeking treatment for PCOD induced infertility |
|
| ExclusionCriteria |
| Details |
Under any other serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regulation of menstrual cycle and harmonal profile. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disappearance/reduction in the size or number of cysts. |
3 months |
|
|
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)
|
02/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 05-06-2025 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
PCOD is a multifactorial and polygenic condition, manifested by amenorrhea, hirsutism and obesity associated with enlarged polycystic ovaries.This complex endocrine disorder occurs at a frequency of 11.2% in women of reproductive age group.It was first described by Stein and Leventhal in 1935 and is linked with anovulation. It is now recognized as a common, heterogeneous heritable disorder affecting women throughout their lifetime. In Siddha system of Medicine, there are unique combinations of medicines which have solutions to the present scenario of PCOD. One such combination is SOOSIKA CHOORANAM which will be more effective and reliable. The method of preparation of the medicine is easy and the raw drugs are also easily available.
|