| CTRI Number |
CTRI/2026/02/103125 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study on Clinical evaluation of Aavarai Panjangula Kuzhi Thylam for Diabetes mellitus patients attending at GSMC OPD |
|
Scientific Title of Study
|
Standardization and Clinical evaluation of Aavarai Panjangula Kuzhi Thylam - a case series |
| 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 Jayasri Kavya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Dept of Gunapadam,
Government Siddha Medical College,
Arumbakkam,
Chennai-106
Aringnar Anna Hospital Campus,
Arumbakkam,
Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
7904729567 |
| Fax |
|
| Email |
gjayasrikavya2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MD Saravanadevi |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College |
| Address |
Dept of Gunapadam,
Government Siddha Medical College,
Arumbakkam,
Chennai-106
Aringnar Anna Hospital Campus,
Arumbakkam,
Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444693840 |
| Fax |
|
| Email |
saravanadhevi1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MD Saravanadevi |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College |
| Address |
Dept of Gunapadam,
Government Siddha Medical College,
Arumbakkam,
Chennai-106
Aringnar Anna Hospital Campus,
Arumbakkam,
Chennai-106
TAMIL NADU
600106
India |
| Phone |
9444693840 |
| Fax |
|
| Email |
saravanadhevi1965@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
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 Jayasri Kavya |
Government Siddha Medical College, Chennai |
Department of PG Gunapadam,
Room no. S18, Government Siddha Medical College, Arumbakkam, Chennai-106
Chennai
TAMIL NADU |
7904729567
gjayasrikavya2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Siddha medical College, Arumbakkam, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aavarai Panjangula Kuzhi Thylam |
Aavarai Panjangula Kuzhi Thylam (APKT), is composed of five parts of Aavarai (Cassia auriculata)—root, bark, seed, leaf, and flower. 35gms of each ingredients get crushed and put into the earthen pot and subjected to Kuzhi Thylam process. 4.2 gms of medicine will be given with hotwater for 20 days/ 40 days according to disease condition. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are having classical symptoms like Polyuria, Polyphagia, Poly dypsia, Nocturia, Fatigue and having Blood Glucose fasting ranges from 126 to 140 milligram per decilitre
Blood Glucose postprandial ranges from 180 to 280 milligram per decilitre
HbA1C from 6.5 to 8 percent |
|
| ExclusionCriteria |
| Details |
Known case of Insulin Dependent Diabetes Mellitus, Cardiovascular Disease, Diabetic Nephropathy and Retinopathy, Hyper cholestrolemia
Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the evaluation of siddha trial drug Aavarai Panjangula kuzhi thylam in Madhumegam patients. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction of clinical symtoms before and after treatment |
3 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 2 |
|
Date of First Enrollment (India)
|
24/02/2026 |
| 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="0"
Months="3"
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gjayasrikavya2000@gmail.com].
- For how long will this data be available start date provided 07-10-2025 and end date provided 07-10-2030?
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 clinical study evaluates the effectiveness of Aavarai Panjangula Kuzhi Thylam(APKT), a siddha formulation indicated for Madhumegam, among patients attending the outpatient department at Government Siddha Medical College, Chennai. The drug is prepared using five parts of Cassia auriculata (root, stem, bark, leaf, flower) as per classical Siddha text Anuboga Vaidhiya Navaneedham, part 2. The study follows a case series design with a sample size of 20 patients over a three month period. Patient diagnosed with type 2 diabetes were selected based on inclusion and exclusion criteria. The therapeutic response was assessed through clinical symptoms and biochemical parameters such as fasting and postprandial blood glucose and HbA1C levels before and after treatment. The study helps to evaluate the effectiveness of APKT and helps to assess the reduction of clinical symptoms. And it helps for future large scale clinical evaluation. |