CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2023/10/058245 [Registered on: 04/10/2023] Trial Registered Prospectively

Last Modified On:

17/11/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A clinical trial to study the effects of two drugs, Eranda saptaka kwatha and Rasonadi kwatha in patient with pain and stiffness associated with Amavata.

Scientific Title of Study

A single blind randomized comparative clinical study to evaluate the efficacy of Eranda saptaka kwatha and Rasonadi kwatha in the management of Stabdhata and Ruja associated with Amavatha.

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 Samprath Nayak
Designation	PG scholar
Affiliation	ALN Rao Memorial Ayurvedic Medical College
Address	Department of Kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, Kachkal road, Koppa. Chikmagalur KARNATAKA 577126 India
Phone	7892359808
Fax
Email	samprathnayaks@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Prashanth Bhat
Designation	HOD and Professor
Affiliation	ALN Rao Memorial Ayurvedic Medical College
Address	Department of Kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, kachkal road, Koppa. Chikmagalur KARNATAKA 577126 India
Phone	7619412593
Fax
Email	drprashanthbhat@outlook.com

Details of Contact Person
Public Query

Name	Dr Samprath Nayak
Designation	PG scholar
Affiliation	ALN rao memorial ayurvedic medical college
Address	Department of Kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, kachkal road, Koppa. Chikmagalur KARNATAKA 577126 India
Phone	7892359808
Fax
Email	samprathnayaks@gmail.com

Source of Monetary or Material Support

Department of kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, koppa , Chikmagaluru Dist, 577126.

Primary Sponsor

Name	Dr Samprath Nayak
Address	Department of Kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, Koppa, Chikmagalur Dist, 577126.
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 Samprath Nayak	ALN Rao memorial Ayurvedic Medical College and Hospital	Kayachikitsa OPD, ALN Rao Memorial Hospital, Kachkal road, Koppa. Chikmagalur KARNATAKA	7892359808 samprathnayaks@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Aroor Laxminarayana Rao Memorial AYURVEDIC MEDICAL COLLEGE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M069\|\|Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Eranda Saptaka Kwatha, Reference: Chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Rasonadi Kwatha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patients of age group above 20 years and below 60 years 2. Patients diagnosed as Amavata on basis of Classical Lakshanas, specifically considering Stabdhata and Ruja for study. 3. Patient with controlled systemic diseases.

ExclusionCriteria

Details

1. Patients below 20 years and above 60 years.
2. Other complicated joint disorders.
3. Complications including deformities, contractures and nodules.
4. Other serious systemic complicated disease.

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Pain stiffness	30 days

Secondary Outcome

Outcome	TimePoints
not applicable	not applicable

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 2/ Phase 3

Date of First Enrollment (India)

10/10/2023

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

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

This is a single blind randomized comparative clinical study to evaluate the effect of eranda saptaka kwatha and rasonadi kwatha for 30 days. This study comprise of two groups of 30 subjects with pain and stiffness associated with Amavata. Study will be conducted in ALN Rao memorial ayurvedic hospitals in koppa and quard hitlow places, koppa taluk, chikmagaluru distric 577126, karnataka, india. Primary out come measure will be Ruja(pain) and Stabdhata(stiffness) fin 30 days.