CTRI

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CTRI Number

CTRI/2023/10/058497 [Registered on: 10/10/2023] Trial Registered Prospectively

Last Modified On:

15/09/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Other (Specify)

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison between efficacy of trinapanchmoola kashaya and punarnava kashaya in mutradoshvikara with special reference to chronic kidney disease

Scientific Title of Study

A comparative clinical study to assess the efficacy of trinapanchmoola kashaya and punarnava kashaya in the management of mutradoshvikara w.s.r.to chronic kidney disease

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 Sunil Thakur
Designation	Reader
Affiliation	Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital
Address	Room no 317 Kayachikitsa Department Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt Kangra Kangra HIMACHAL PRADESH 176115 India
Phone	9816195001
Fax
Email	dr.skumarthakur@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Anjana Mishra
Designation	Head of Department
Affiliation	Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Address	Room no 317 Kayachikitsa Department Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt kangra Kangra HIMACHAL PRADESH 176115 India
Phone	9418312324
Fax
Email	dranjana269@gmail.com

Details of Contact Person
Public Query

Name	Mahima
Designation	P. G. Scholar
Affiliation	Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital, Paprola
Address	Room no 317 Kayachikitsa Department Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt Kangra Kangra HIMACHAL PRADESH 176115 India
Phone	8278765286
Fax
Email	maahic35@gmail.com

Source of Monetary or Material Support

Charak Pharmacy, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola

Primary Sponsor

Name	Dr Sunil Thakur
Address	Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt Kangra HIMACHAL PRADESH
Type of Sponsor	Government medical college

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 Sunil Thakur	Rajiv Gandhi Govt Post Graduate Ayurvedic College & Hospital	Room No 317 Kayachikitsa Department of Hospital building Kangra HIMACHAL PRADESH	9816195001 dr.skumarthakur@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee (Human)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N189\|\|Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAGHATAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Trinpanchmool kashaya, Reference: Shushruta Sutra sthan 38/77, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Punarnava kashaya , Reference: API part 1 volume 1, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients of chronic kidney disease having blood urea 50 to 100 mg/dl, S. Creatinine 1.3 to 4.0 mg/dl and eGFR between 45 to 90 ml/min/1.73m2

ExclusionCriteria

Details

Patients with advanced renal failure with b urea >100mg/dl and S creatinine >4.0 mg/dl
Patients suffering from other major illness like carcinoma or PTB

Method of Generating Random Sequence

Other

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
A comparative clinical study to assess the efficacy of trinpanchmoola kashaya & punarnava kashaya in the management of mutradoshvikara w.s.r. to chronic kidney disease	12 weeks

Secondary Outcome

Outcome	TimePoints
To assess the clinical safety of trinapanchmoola kashaya & punarnava kashaya in the management of mutradoshvikara w s r to chronic kidney disease	12 weeks

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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 4

Date of First Enrollment (India)

15/10/2023

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

I would like to publish my work after completion of my research work as soon as possible. Patients will be selected from OPD and IPD of Kayachikitsa Department of Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt Kangra. 30 Patients will be divided into two groups and a comparative study will be made to evaluate the efficacy of trinpanchmoola kashaya and punarnava kashaya in the management of mutradoshvikara w s r Chronic kidney disease.