CTRI

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CTRI Number

CTRI/2025/01/079028 [Registered on: 20/01/2025] Trial Registered Prospectively

Last Modified On:

17/01/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

To compare the effect of Gokantakadi Kashaya with Nishakathakadi Kashaya in reducing blood sugar level in Type 2 Diabetes Mellitus

Scientific Title of Study

A comparative study of Gokantakadi Kashaya with Nishakathakadi Kashaya in Type 2 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	Dr Meenu R Menon
Designation	PG Scholar
Affiliation	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital
Address	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur Thrissur KERALA 679531 Thrissur KERALA 679531 India
Phone	8589042028
Fax
Email	lathamenonravi28@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vinitha C
Designation	Associate Professor, Department of Kayachikitsa
Affiliation	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital
Address	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur Thrissur KERALA 679531 Thrissur KERALA 679531 India
Phone	9497062425
Fax
Email	drvinithasujith@gmail.com

Details of Contact Person
Public Query

Name	Dr Ratheesh P
Designation	Professor HOD, Department of Kayachikitsa
Affiliation	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital
Address	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur Thrissur KERALA 679531 Thrissur KERALA 679531 India
Phone	9846889793
Fax
Email	drrpnair07@gmail.com

Source of Monetary or Material Support

Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital Cheruthuruthy Thrissur KERALA INDIA PIN-679531

Primary Sponsor

Name	Meenu R Menon
Address	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital, Cheruthuruthy, Thrissur Thrissur KERALA 679531
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 Meenu R Menon	Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital	Department of Kayachikitsa Room no 01 Thrissur Kerala 679531 Thrissur KERALA	8589042028 lathamenonravi28@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee PNNM Ayurveda Medical 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: PRAMEHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Gokantakadi Kashaya, Reference: Vaidya Manorama, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Nishakathakadi Kashaya, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Participants fulfilling the diagnostic criteria FBS 126mg/dl to 250mg/dl or PPBS 200mg/dl to 350mg/dl or In a patient with classical signs and symptoms of hyperglycemia, RBS 200mg/dl to 350mg/dl Participants willing to give informed consent

ExclusionCriteria

Details

Participants diagnosed with Type 1 Diabetes mellitus, Participants with Type 2 Diabetes mellitus under medications, participants who are known cases of other systemic illness,Type 2 Diabetes mellitus with known complications like diabetic retinopathy,
neuropathy, nephropathy, Pregnant and lactating womens, Participants who are known cases of psychiatric illness,

Method of Generating Random Sequence

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

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
FBS PPBS RBS	0th day 15th day and 31st day

Secondary Outcome

Outcome	TimePoints
Polyuria Polyphagia Polydipsia Excessive Sweating Fatigue	0th day, 15th day and 31st day

Target Sample Size

Total Sample Size="52"
Sample Size from India="52"
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/ Phase 3

Date of First Enrollment (India)

01/02/2025

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="1"
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

In this study, an attempt is made to compare the effect of Gokantakadi Kashaya and Nishakathakadi Kashaya in the Management of Type 2 Diabetes Mellitus. Out come measures includes FBS, PPBS, RBS, Polyuria, Polyphagia, Polydipsia, Excessive sweating, Fatigue.