| CTRI Number |
CTRI/2026/03/105113 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect of siddha medicine Bojana Kudori Mathirai in patients with Soothaga Vaayu (Polycystic Ovarian Disease) |
|
Scientific Title of Study
|
Single centric Phase II open clinical trial in Soothaga Vaayu (Polycystic Ovarian Disease) with siddha medicine Bojana Kudori Mathirai |
| 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 V MAHALAKSHMI SWAATHY |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9940351428 |
| Fax |
|
| Email |
maha30069900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K SUDHAMATHI PUSHPARAJ |
| Designation |
PROFESSOR & HOD |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445118473 |
| Fax |
|
| Email |
sudhamathipushparaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K SUDHAMATHI PUSHPARAJ |
| Designation |
PROFESSOR & HOD |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, CHENNAI |
| Address |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai
TAMIL NADU
600106
India |
| Phone |
9445118473 |
| Fax |
|
| Email |
sudhamathipushparaj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr V MAHALAKSHMI SWAATHY |
| Address |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai |
| 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 V MAHALAKSHMI SWAATHY |
GOVERNMENT SIDDHA MEDICAL COLLEGE, ARUMBAKKAM, CHENNAI |
Room No S1, PG Department of Pothu Maruthuvam, Government Siddha Medical College , Arumbakkam ,Chennai - 600106
Chennai
TAMIL NADU |
9940351428
maha30069900@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 |
| Intervention |
BOJANA KUDORI MATHIRAl |
35 gm of Zingiber officinale, Ferula asafoetida, Zingiber officinale, Sodium chloride impura, Cuminum cyminum, Piper nigrum, purified and grinded using lemon juice in a stone and motor pestle for 6 hours. Sundaikai Alavu (798mg) pills will be made and dried under the shade and stored in an airtight container.
DOSAGE:Sundaikai Alavu(798mg)
Once in a day in morning
DURATION: 3 months
ADJUVANT:Water |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Polysystic appearance of ovaries (Unilateral/Bilateral) |
|
| ExclusionCriteria |
| Details |
Previous K/C/H/O of Endocrine disease
Previous K/C/H/O of any serious systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is mainly assessed by,
1. Disappearance/reduction in the size or number of cysts in ultrasonogram(Abdomen and pelvis) |
It is mainly assessed by,
1. Disappearance/reduction in the size or number of cysts in ultrasonogram(Abdomen and pelvis) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is mainly assessed by,
1. Disappearance/reduction in the size or number of cysts in ultrasonogram(Abdomen and pelvis) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
23/03/2026 |
| 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 Yet Recruiting |
| 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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [maha30069900@gmail.com].
- For how long will this data be available start date provided 23-03-2026 and end date provided 11-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is Signal centric phase 2 open clinical trial in SOOTHAGA VAAYU (POLYCYSTIC OVARIAN DISEASE) with siddha medicine BOJANA KUDORI MATHIRAI The dosage of BOJANA KUDORI MATHIRAI is Sundaikai Alavu (798 mg) Outcome is mainly assessed by Disappearance/reduction in the size or number of cysts in ultrasonogram(Abdomen and pelvis)
|