CTRI

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CTRI Number

CTRI/2025/09/094359 [Registered on: 08/09/2025] Trial Registered Prospectively

Last Modified On:

08/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Amrita guggulu and Rasonadi kwath will be given to the patient of Amavata

Scientific Title of Study

COMPARATIVE CLINICAL STUDY OF AMRITA GUGGULU & RASONADI KWATH IN AAMVATA

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	PREETI KALONI
Designation	PG SCHOLAR
Affiliation	UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS
Address	OPD 5 DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR 249404 UTTARAKHAND Hardwar UTTARANCHAL 249404 India
Phone	8941066968
Fax
Email	pkaloni02@gmail.com

Details of Contact Person
Scientific Query

Name	Dr PUNITA PANDEY
Designation	PROFESSOR
Affiliation	UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS
Address	OPD 5 DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR 249404 UTTARAKHAND Hardwar UTTARANCHAL 249404 India
Phone	9319394485
Fax
Email	pandey.punita62@gmail.com

Details of Contact Person
Public Query

Name	PREETI KALONI
Designation	PG SCHOLAR
Affiliation	UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS
Address	OPD 5 DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR 249404 UTTARAKHAND Hardwar UTTARANCHAL 249404 India
Phone	8941066968
Fax
Email	pkaloni02@gmail.com

Source of Monetary or Material Support

PREETI KALONI PG SCHOLAR DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR 249404

Primary Sponsor

Name	PREETI KALONI
Address	PG DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR
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
PREETI KALONI	UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR	OPD 5 DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR 249404 UTTARAKHAND Hardwar UTTARANCHAL	08941066968 pkaloni02@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M059\|\|Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Amrita Guggulu, Reference: Bhavprakash madhyam khand, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information:
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Rasonadi kwath, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. PATIENT WITH CLASSICAL SIGN AND SYMPTOMS OF AAMVATA 2. CHRONICITY UPTO 5 YEARS

ExclusionCriteria

Details

1. PATIENT WHO HAS DEVELOPED COMPLICATION OF RHEUMATOID ARTHRITIS EXAMPLE SEVERE DEFORMITY OF JOINTS AND BONES
2. CHRONICITY MORE THAN 5 YEARS
3. OSTEOARTHRITIS
4. GOUTY ARTHRITIS
5. PREGNANT AND LACTATING WOMEN
6. PATIENTS SUFFERING FROM ANY SERIOUS MEDICAL OR SURGICAL ILLNESS

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
RELIEF IN SUBJECTIVE PARAMETERS 1 SANDHISHOOLA (JOINT PAIN) 2 SANDHISHOTH (JOINT SWELLING) 3 SPARSHASAHATWA (TENDERNESS) 4 SANDHISTABDHATA (MORNING STIFFNESS) 5 APAKA (INDIGESTION) 6 ARUCHI 7 JWARA (FEVER) 8 GAURAVATA (HEAVINESS IN THE BODY) 9 BAHUMUTRATA (FREQUENCY OF MICTURITION) 10 UTSAHAHANI (LOSS OF VIGOUR)	4 weeks to 8 weeks

Secondary Outcome

Outcome	TimePoints
RELIEF IN OBJECTIVE PARAMETERS 1 RHEUMATOID FACTOR 2 CRP 3 ESR 4 ANTI CCP 5 RING TEST	ASSESSMENT WILL BE DONE ON 1ST DAY 30TH DAY 60TH DAY AND 90 DAYS

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

10/10/2025

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

THIS STUDY IS COMPARATIVE CLINICAL STUDY OF AMRITA GUGGULU & RASONADI KWATH IN AAMVATA FOR THE AGE GROUP BETWEEN 20 TO 60 YEARS FOR DURATION OF 90DAYS . THIS STUDY WILL BE CONDUCTED AT UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR ON 40 PATIENTS. IN THIS STUDY 20 PATIENTS WILL BE ADMINISTERED AMRITA GUGGULU AND 20 PATIENTS WILL BE ADMINISTERED RASONADI KWATH FOR 90 DAYS. THE ASSESSMENT WILL BE DONE ON THE BASIC OF SUBJECTIVE AND OBJECTIVE PARAMETERS . THE STUDY WILL BE CONDUCTED AT OPD AND IPD LEVEL OF PG DEPARTMENT OF KAYACHIKITSA. THE ASSESSMENT WILL BE DONE AT THE INTERVAL OF 30 DAYS OF CLINICAL TRIAL. THE RESULT OBTAINED WILL BE TABULATED AND STATISTICALLY ANALYSED USING APPROPRIATE TEST.