CTRI

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CTRI Number

CTRI/2024/09/074351 [Registered on: 25/09/2024] Trial Registered Prospectively

Last Modified On:

22/09/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Biological
Ayurveda
Diagnostic
Preventive
Process of Care Changes

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

To maintain sugar level by ayurveda medicine

Scientific Title of Study

A COMPARATIVE STUDY OF INDRAVARUNI PHAL (Citrullus colocynthis schard.) AND AMA UDUMBARA PHAL (Ficus racemosa Linn) ON MADHUMEHA W.S.R. OF DIABETES MELLITUS"

Trial Acronym

DIABETES MELLITUS, MADHUMEH, SUGAR

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr pooja sahu
Designation	Pg scholar in department of gravyaguna vigyana
Affiliation	GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP
Address	GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP Ujjain MADHYA PRADESH 456001 India
Phone	8889420464
Fax
Email	ps8370186@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shiromani Mishra
Designation	Reader of Department of Dravyaguna Vigyana
Affiliation	GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP
Address	GOVERNMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP Ujjain MADHYA PRADESH 456001 India
Phone	9893158853
Fax
Email	shiromishra@gmail.com

Details of Contact Person
Public Query

Name	Dr Shiromani Mishra
Designation	Reader of Department of Dravyaguna Vigyana
Affiliation	GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP
Address	GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP Ujjain MADHYA PRADESH 456001 India
Phone	9893158853
Fax	00
Email	shiromishra@gmail.com

Source of Monetary or Material Support

OPD NO 52 DEPARTMENT OF DRAVYAGUNA VIGYANA GOVERNMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP

Primary Sponsor

Name	Goverment Dhanwantri Ayurveda College UJjain Madhyapradesh india
Address	OPD NO 52 Department of Dravyaguna vigyana Goverment Dhanwanti ayurveda college Ujjain madhyapradesh india
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP	OPD NO 52 DEPARTMENT OF DRAVYAGUNA VIGYANA GOVERMENT DHANWANTRI AYURVEDA COLLEGE AND HOSPITAL UJJAIN MP

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr POOJA SAHU	Goverment Dhanwantri ayurveda college and hospital ujjain madhyapradesh india	opd no 52 goverment dhanwantri ayurveda college and hospital ujjain MP Ujjain MADHYA PRADESH	8889420464 00 ps8370186@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Insttutinal Ethical committee govt Dhanwantri Ayurveda college and hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E119\|\|Type 2 diabetes mellitus without complications. Ayurveda Condition: type 2 diabetes mellitus, (2) ICD-10 Condition:E119\|\|Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Indravaruni phala churna, Reference: Bhavaprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Ama Udumber phala, Reference: Kaiyadeva nighantu Osadhi varge slok no. 429, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: leukwarm water), Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	AGE FROM 20 YEARS AGE TO 65 YEARS GENDER BOTH FBS MORE THAN 126 mg/dl TO 200 mg/dl PPBS MORE THAN 200 mg/dl TO 350 mg/dl HbA1C 5.7 TO 6.5

ExclusionCriteria

Details

AGE MORE THAN 65 YEARS
FBS MORE THAN 200 mg/dl
PPBS MORE THAN 350 mg/dl
HbA1C MORE THAN 6.5
HTN AND PREGNANT LACTATING WOMAN
CKD AND EMERGENCY CASES OF DM

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
REDUCE THE SYMPTOMS OF DM	60 DAYS

Secondary Outcome

Outcome	TimePoints
IMPROVE THE QUALITY OF LIFE	60 days

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2

Date of First Enrollment (India)

15/10/2024

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="4"
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 mellitus is a metabolic disease which affect the most of the population now a days and our ayurveda medicine is able to maintain normal blood glucose level.