| CTRI Number |
CTRI/2026/02/104392 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| 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 on ayavathi chooranam in the management of deepana silethma noi(dyslipidemia) |
|
Scientific Title of Study
|
A prospective open labelled, single
arm, non - randomized, single centric,
phase II clinical trial to determine
the effectiveness of ayavathi
chooranam in the management of
deepana silethma noi (dyslipidemia) |
| 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 Vandhana Sai |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, PG Second Year
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9489677617 |
| Fax |
|
| Email |
vandhanagt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Uma Kalyani MD S |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7598253499 |
| Fax |
|
| Email |
sukgsmc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Justus Antony MD S |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government Siddha Medical College and Hospital Palayamkottai Thirunelveli 627002 India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital Thiruvanathapuram road Palayamkottai Tirunelveli 627002 |
| 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 VANDHANA SAI |
Government Siddha Medical College and Hospital |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli 627002
Tirunelveli
TAMIL NADU |
9489677617
vandhanagt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College Palayamkottai Thirunelveli 627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayavathi Chooranam |
Dosage:1 varaganedai (4.2gram)twice a day for 48 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of primary dyslipidemia
2.TC above 200 mg/dl, LDL above 130mg/dl, VLDL above 30mg/dl, TG above 200mg/dl
3.Having not taking any lipid lowering drugs for the past 1 month
4.Able to adhere to long term treatment
5.Willing and able to follow scheduled visit plan,
diet and exercise instructions, lab tests and other procedures
6.Having voluntarily given their informed consent. |
|
| ExclusionCriteria |
| Details |
Combined with any cardiac disorders
Combined with any liver disorders
Renal disorders
Pregnancy and lactating women
Participated in any clinical trials of other drug in the past 4 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the clinical efficacy of Ayavathi chooranam (internal) in the management of Deepana silethma noi (Dyslipidemia) and to evaluate the changes in LDL from baseline to week 12. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collect various siddha literatures and modern journals for literature review on Deepana silethma noi.
To study other cofactors related to disease like age, sex, dietary habits, family history and socioeconomic status.
To evaluate pharmacological activities of ayavathi chooranam.
To study about the prevalence of deepana silethma noi in relation with diet and lifestyle.
To evaluate the siddha parameters (including envagai thervu, neerkuri, neikuri) during trial period.
To evaluate modern parametric changes.
To evaluate the change in serum TC, HDL at 48th day.
To document biostatistical analysis. |
6 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)
|
25/03/2026 |
| 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="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 - NO
|
|
Brief Summary
|
This study is a prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of AYAVATHI CHOORANAM in the management of DEEPANA SILETHMA NOI(DYSLIPIDEMIA). After purifictaion of trial drugs ayavathi chooranam will be prepared and administered for 48 days for 40 patients.The primary outcome will be to determine the clinical efficacy of ayavathi chooranam (internal) in the management of dyslipidemia and to evaluate the changes in LDL anf TG from baseline to 48th day. The secondary outcome will be to collect various aspects of deepana silethma noi in siddha literatures, to evaluate pharmacological analysis of ayavathi chooranam, to study about the prevalence of deepana silethma noi in relation between diet and lifestyle, to evaluate siddha parameters (including envagai thervu, neerkuri, neikuri) changes in deepana silethma noi, to evaluate the change in serum TC,LDL at 48th day, to document the biostatistical analysis, to assess the quality of life of deepana silethma noi patients. |