| CTRI Number |
CTRI/2026/02/103076 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two Siddha medicines (Avaraiyathi Chooranam and Madhumega Chooranam) for controlling blood sugar in participants with Type 2 Diabetes at National Institute of Siddha, Chennai |
|
Scientific Title of Study
|
A Comparative Study on the effect of the Avaraiyathi Chooranam and Madhumega Chooranam in the management of Madhumegam (Diabetes Mellitus -Type II) – An Open label, Randomized controlled trial in patients reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HITHA SHYAM MS |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Pothu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047
Chennai
TAMIL NADU
600047
India |
| Phone |
8610774064 |
| Fax |
|
| Email |
hithashyam1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Professor, Head Of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Pothu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047
Chennai
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HITHA SHYAM MS |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Pothu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047
Chennai
TAMIL NADU
600047
India |
| Phone |
8610774064 |
| Fax |
|
| Email |
hithashyam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamil Nadu, India, Pin Code 600047 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 HITHA SHYAM MS |
National Institute of Siddha |
Department of Pothu Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai 600047
Chennai
TAMIL NADU |
8610774064
hithashyam1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee |
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 |
Avaraiyathi Chooranam |
Internal Medicine
5 gram Twice a day with Hot Water for 90 days |
| Comparator Agent |
Madhumega Chooranam
|
Internal Medicine
2 Capsules Twice a day with Hot water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Glycosylated Hemoglobin (HbA1c) More than 6.5 percent and Less than 9 percent
Newly diagnosed type II diabetes mellitus patients |
|
| ExclusionCriteria |
| Details |
Participants of Type-I DM (insulin dependent DM) or Type-II DM on insulin
Participants with current diagnosis of malignancy Participants suffering from major systemic illness necessitating long term drug treatment (TB, AIDS)
Pregnant and Lactating women
Participants who have participation in any other clinical trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference of objective parameter HbA1c, Serum fasting glucose and postprandial glucose in both arms (Minimal Clinical Importance Difference of HbA1c-0.5 Percent)
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference of Fasting lipid sub fractions in both arms.
Difference of HOMA IR test in sub groups (20 patients from each group- every 5th person) at base line and after 3 months.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="10"
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
|
Type II Diabetes mellitus participants will be screened. Participants will be informed about the objective of the study. Complete clinical history, complaints and duration, examination findings all will be recorded. Study participants will be allocated in to group “A” and group “M” by Randomization. Blood investigations (FBS & PPBS) will be done at base line, 30th day, 60th day and 90th day. HbA1c, HOMA IR (for sub group, every 5th person of each group) will be checked on base line and 90th day. The participants will be given study drug Avaraiyathi Chooranam and Madhumega Chooranam 15 days once for a period of 90 days. All enrolled participants will be recommended to follow the diet chart and advised not to take any other anti-diabetic drugs during the study period of 3 months. Base line and at the end of 3 months along with blood sugar, lipid profile, hematology, renal and liver function test will be performed. After completion of study patient can follow with OPD medicines. |