| CTRI Number |
CTRI/2026/01/101237 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Effect of Saladi Churna and an Ayurvedic Diet in Controlling Blood Sugar Levels in People with Type 2 Diabetes |
|
Scientific Title of Study
|
A PRE AND POST TEST CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF PRAMEHARA PROPERTY OF SALADI CHURNA and AYURVEDIC DIETARY PROTOCOL IN TYPE II DIABETES MELLITUS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VijayarajaaP |
| Designation |
Assistant Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital. |
| Address |
4/295 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarethpet Chennai.
Chennai
TAMIL NADU
600123
India |
| Phone |
7598366065 |
| Fax |
|
| Email |
vijayarajaa@sjsach.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
VijayarajaaP |
| Designation |
Assistant Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital. |
| Address |
4/295 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarethpet Chennai.
Chennai
TAMIL NADU
600123
India |
| Phone |
7598366065 |
| Fax |
|
| Email |
vijayarajaa@sjsach.org.in |
|
Details of Contact Person
Public Query
|
| Name |
VijayarajaaP |
| Designation |
Assistant Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital. |
| Address |
4/295 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarethpet Chennai.
Chennai
TAMIL NADU
600123
India |
| Phone |
7598366065 |
| Fax |
|
| Email |
vijayarajaa@sjsach.org.in |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai |
|
|
Primary Sponsor
|
| Name |
Chhattisgarh Tribal Local Health Traditions and Medicinal Plants Board |
| Address |
Chhattisgarh Tribal Local Health Traditions Medicinal Plants Board located at State Forest Training Research Institute Campus Zero Point Baloda Bazar Road Raipur 493111 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| VijayarajaaP |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Department of Kayachikitsa
Chennai
TAMIL NADU |
07598366065
vjrajaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL |
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. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saladi Churna, Reference: Chakradutta, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Amalaki Swarasa), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18-60 years age of either sex.
Patients willing to take part in a research study and ready to give written informed consent
Patients diagnosed with the symptoms of Diabetes and have a HbA1C value between
5.7% -6.4%
|
|
| ExclusionCriteria |
| Details |
We excluded studies of patients with type 1 diabetes, impaired glucose tolerance, metabolic syndrome, maturity onset diabetes of youth, and gestational diabetes.
We excluded studies if they included only pregnant women or subjects 17 years of age or younger.
We excluded studies where everyone was required to have at least one of the following co-morbid ]conditions: ESLD, ESRD, cancer, new onset diabetes after organ transplant, or a recent
cardiovascular event within the 3 months prior to
study start.
Pregnant and Lactating Mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the synergistic effect of Saladi Churnaand Ayurvedic dietary protocol in improving glycaemic control in patients with Type II Diabetes Mellitus.
To explore the synergistic effect of Saladi Churna and Ayurvedic dietary protocol on overall improvement in the quality of life in patients with Type II Diabetes Mellitus |
Baseline Assessment -ON 0th day.
Post Treatment Assessment- 91st day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
27/01/2026 |
| 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="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 is the first of its kind clinical study
evaluating the synergistic effect of Saladi Churna and an
Ayurvedic dietary protocol in Type II Diabetes Mellitus. The novelty of this
study lies in integrating Saladi Churna with a
comprehensive Ayurveda dietary protocol to manage Type II Diabetes Mellitus, a
combination not extensively explored in modern clinical research. By assessing
the complete diabetic profile before and after the intervention, this study
aims to provide robust evidence for holistic Ayurvedic approaches in diabetes
care. |