CTRI

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CTRI Number

CTRI/2025/07/089969 [Registered on: 02/07/2025] Trial Registered Prospectively

Last Modified On:

01/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Other

Public Title of Study

AYURVEDIC MANAGEMENT IN MADHUMEHA(PRAMEHA-DIABETIS)

Scientific Title of Study

Randomized controlled comparative clinical study to evaluate the efficacy of Gudmar Ghanvati with parijatak ghanvati in type-II Diabetes Mellitus w.s.t Prameha

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. Sagar Laxman Gawali
Designation	PG Scholar Kayachikitsa Dept.
Affiliation	ASS, Ayurvedic Mahavidyala Nashik
Address	Kayachikitsa OPD NO 14 AROGYASHALA RUGNALAYA GANESHWADI,PANCHAWATI,NASHIK Kayachikitsa OPD NO 14 AROGYASHALA RUGNALAYA GANESHWADI,PANCHAWATI,NASHIK Nashik MAHARASHTRA 422003 India
Phone	8208304758
Fax
Email	sagargawali9049@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sanjiani Nitin Rathod
Designation	MD KAYACHIKITSA
Affiliation	ASS, Ayurvedic Mahavidyala Nashik
Address	AROGYASHALA RUGNALAYA GANESHWADI NASHIK AROGYASHALA RUGNALAYA GANESHWADI NASHIK MAHARASHTRA 422003 India
Phone	8007229141
Fax
Email	sanjivanirathod431@gmail.com

Details of Contact Person
Public Query

Name	Dr. SAGAR LAXMAN GAWALI
Designation	PG Scholar Kayachikitsa Dept.
Affiliation	ASS, Ayurvedic Mahavidyala Nashik
Address	OPD NO 14 AROGYASHALA RUGNALAYA GANESHWADI,PANCHAWATI,NASHIK OPD NO 14 AROGYASHALA RUGNALAYA GANESHWADI,PANCHAWATI,NASHIK MAHARASHTRA 422003 India
Phone	8208304758
Fax
Email	sagargawali9049@gmail.com

Source of Monetary or Material Support

nil

Primary Sponsor

Name	Dr SAGAR LAXMAN GAWALI
Address	AROGYASHALA RUGNALYA GANESHWADI PANCHAVATI NASHIK
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR SAGAR LAXMAN GAWALI	Arogyashala Rugnalaya	Kayachikitsa OPD NO 13 AROGYASHALA RUGNALAYA GANESHWADI PANCHAVATI NASHIK 422003 Nashik MAHARASHTRA	8208304758 sagargawali9049@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL COMMITEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E118\|\|Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: PRAMEHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: gudmarghanvati, Reference: Bhavmishra .Bhavprakash,Edited by G S Pandey ,p.443,shlok no. 254,255, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Parijatak Ghanvati, Reference: Dr.Bramhanand Tripathi Charak samhita, charak chandrika part 1, reprint 2006, chaukhamba prakasha charak sutrasthan 6., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: koshna jal), Additional Information: -

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Age group in between 30 –70 years 2. Patient of any gender,religion and socio-economic status. 3. Patient having signs and symptoms of prameha 4. HbA1C (6.5 to 9%) 5. Patients willing to participate with informed written consent.

ExclusionCriteria

Details

1. IDDM patients
2. Juvenile Diabetes, Acromegaly, Cushing’s syndrome, pancreatic disorders.
3. Pregnancy, Unconscious patients.
4. Conditions like Cardiovascular disease, acute myocardial infarction,
immune-compromised disease(HIV)
5. HbA1C less than 6.5% and greater than 9%

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Does the Gudmar Ghanvati is effective in Prameha ?	90 days

Secondary Outcome

Outcome	TimePoints
To study the comparative effect of Gudmar Ghanvati & parijatak ghanvati on sign & symptoms of prameha	90 days

Target Sample Size

Total Sample Size="66"
Sample Size from India="66"
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)

20/07/2025

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="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 - NO

Brief Summary

Diabetes is a life threatening disease and its global burden is around 80- 95%. Diabetes mellitus causes not only psychological and physical distress to patients, but also some serious and even life-threatening complications. Prolonged hyperglycemia affects almost every organ and system in the body, especially the eyes, kidneys, heart, feet, and nerves.As there are many patients of Prameha, there is need of study with different treatment modalities.In Ayurveda Gudmar Ghanvati is choice for Newly diagnosed Diabetic patients which is useful to breakdown pathophysiology by their ras virya & vipaka. Hence the topic is chosen for the study. It is cost effective and simple formulation.