| CTRI Number |
CTRI/2025/10/095934 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [NIL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effectiveness of Keezhanelli Chooranam (KNC) in improving blood sugar control in newly diagnosed Type 2 diabetes patients compared to Madhumegam Chooranam. |
|
Scientific Title of Study
|
Validation of the therapeutic efficacy of the Siddha
herbal formulation Keezhanelli Chooranam (KNC) for managing
newly diagnosed patients with Type 2 Diabetes Mellitus
(Madhumegam): A proof of concept Randomized Clinical Trial |
| Trial Acronym |
KNC Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Soruban |
| Designation |
Medical Officer |
| Affiliation |
Siddha Teaching Hospital, Kaithady |
| Address |
Siddha Teaching Hospital, kaithadyu, Jaffna, Sri Lanka
40000
Other |
| Phone |
0094770090311 |
| Fax |
|
| Email |
sorruthiru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Viviyan Sathiyaseelan |
| Designation |
Dean |
| Affiliation |
Faculty of Siddha Medicine |
| Address |
Faculty of Siddha Medicine, University of Jaffna
40000
Other |
| Phone |
0094716222529 |
| Fax |
|
| Email |
dr.vivian@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Soruban |
| Designation |
Medical Officer |
| Affiliation |
Siddha Teaching Hospital, Kaithady |
| Address |
Siddha Teaching Hospital, kaithadyu, Jaffna, Sri Lanka
40000
Other |
| Phone |
0094770090311 |
| Fax |
|
| Email |
sorruthiru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddha Teaching Hospital, Kaithady, 40000 |
|
|
Primary Sponsor
|
| Name |
Dr Soruban |
| Address |
Lowtan Road, Manipay, Jaffna
40000 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Sri Lanka |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Soruban |
Siddha Teaching Hospital |
OPD, Kaitt]hady, Jaffna, Sri Lanka
|
770090311
sorruthiru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH-ETHICS-COMMITTEE-BANDARANAIKE-MEMORIAL-AYURVEDA-RESEARCH-INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MMC, Reference: The Siddha Pharmacopoeia , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KNC , Reference: The Siddha Pharmacopoeia of India, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Screening glycemic levels: FBS 126–250 mg/dL, PPBS 200–300 mg/dL, HbA1c 6.5–8.0% |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes Mellitus or Secondary Diabetes Mellitus
Cardiovascular and Central Nervous System Disease
Diabetes-related complications
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in HbA1c from baseline to 3 months
Change in FBS and PPBS from baseline to 3 months
|
Change in HbA1c from baseline to 3 months
Change in FBS and PPBS from baseline to 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring of adverse events and drug compliance |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="0"
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)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2025 |
| 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)
|
Open to Recruitment |
| 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 randomized clinical trial aims to evaluate the therapeutic efficacy and safety of Keezhanelli Chooranam (KNC), a traditional Siddha herbal formulation, in managing newly diagnosed patients with Madhumegam (Type 2 Diabetes Mellitus). The primary hypothesis is that KNC can significantly reduce fasting and postprandial blood glucose levels, improve glycemic control, and enhance overall patient well-being when compared to standard care or placebo. |