| CTRI Number |
CTRI/2025/11/097329 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of Stress- Induced Diabetes using Jatamansi infusion |
|
Scientific Title of Study
|
Clinical evaluation of Jatamansyadi Infusion as an add-on intervention in Stress triggered Hyperglycaemia in Diabetes Mellitus: A comparative study |
| 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 Prapti Gulhane |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
College of Ayurved
Department of Swasthavritta Evum Yoga
OPD no. 15
Katraj Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7038615060 |
| Fax |
|
| Email |
praptigulhane95.pg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Patil |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital OPD No 15 Department of Swasthavritta evum Yoga, Katraj - Dhankawadi, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9970044572 |
| Fax |
|
| Email |
patil.dhananjay@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhananjay Patil |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital OPD No 15 Department of Swasthavritta evum Yoga, Katraj - Dhankawadi, Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9970044572 |
| Fax |
|
| Email |
patil.dhananjay@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Bharati Education Campus
Pune - Satara Road
Katraj Dhankwadi Pune - 411043
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Self Dr Prapti Gulhane |
| Address |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj - Dhankawadi, Pune. |
| Type of Sponsor |
Private 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 Prapti Gulhane |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, |
Department of Swasthavritta Evum Yoga,OPD no.15,Katraj- Dhankawadi, Pune - 411043
Pune
MAHARASHTRA |
7038615060
praptigulhane95.pg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE [BV(DU)COA-IEC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E139||Other specified diabetes mellituswithout complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatamansyadi Infusion, Reference: Bhavprakash, Route: Oral, Dosage Form: Phanta, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Infusion | | 2 | Comparator Arm (Non Ayurveda) | | - | Anti Diabetic Drugs | Patients who are consuming Anti Diabetic drugs |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known case of Type 2 Diabetes Mellitus.
Perceived Stress Scale Score more than or equal 14 moderate stress.
Fasting Blood Sugar more than or equal to 126 mg/dL and / Or Post Prandial Blood Sugar (PPBS) more than or equal to 200 mg/dL.
Willingness to participate and comply with protocol. |
|
| ExclusionCriteria |
| Details |
Type 1 DM or insulin-dependent diabetes.
Major psychiatric illness (e.g clinical depression).
Pregnancy/ lactation.
Known case of any systemic or metabolic disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in psychological stress measured by Perceived Stress Scale (PSS-10), with post-treatment score expected to be less than or equal to 14. |
Baseline and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in glycemic parameters
Fasting Blood Sugar (FBS) less than 126 mg/dL
Postprandial Blood Sugar (PPBS) less than 200 mg/dL |
Baseline and 30th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Jatamansyadi infusion is a polyherbal formulation composed of Jatamansi (Nardostachys jatamansi), Brahmi (Bacopa monnieri), Ashwagandha (Withania somnifera), and Green Tea (Camellia sinensis), known for their adaptogenic, antioxidant, and neuroprotective properties. It is prepared as an herbal infusion to help manage psychological stress and improve glycemic control in patients with stress-triggered hyperglycemia. |