CTRI

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

CTRI Number

CTRI/2026/03/106362 [Registered on: 17/03/2026] Trial Registered Prospectively

Last Modified On:

16/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare the effect of Kshara Basti and Erand Bhrisht Haritaki Churna in two group of 20 patients of Amavata w.s.r to Rheumatoid arthritis

Scientific Title of Study

A comparative clinical study to evaluate the efficacy of Kshara Basti and Erand Bhrisht Haritaki Churna in the management of Amavata wsr to Rheumatoid Arthritis

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Archana Rani
Designation	MD (Ay)Scholar (Department of Panchkarma)
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti , Kadamkuan , Patna, Bihar Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna, Bihar Patna BIHAR 800003 India
Phone	9693836399
Fax
Email	drarchanarani20@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Prof Satyendra Kumar Tiwari
Designation	HOD , Department of Panchkarma
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti , Kadamkuan , Patna, Bihar Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna, Bihar Patna BIHAR 800003 India
Phone	9024064735
Fax
Email	satyendratiwari.25@gmail.com

Details of Contact Person
Public Query

Name	Dr Prof Satyendra Kumar Tiwari
Designation	HOD , Department of Panchkarma
Affiliation	Government Ayurvedic College and Hospital Patna
Address	Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti , Kadamkuan , Patna, Bihar Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti, Kadamkuan, Patna, Bihar Patna BIHAR 800003 India
Phone	9024064735
Fax
Email	satyendratiwari.25@gmail.com

Source of Monetary or Material Support

government ayurvedic college and hospital kadamkuan patna, Bihar,India Pin code- 800003

Primary Sponsor

Name	Dr Archana Rani
Address	Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti , Kadamkuan , Patna, Bihar -800003
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 Archana Rani	Government Ayurvedic College and Hospital, Patna	OPD No- 11, Department of Panchkarma Government Ayurvedic College and Hospital, near Buddhamurti , Kadamkuan , Patna, Bihar Patna BIHAR	09693836399 drarchanarani20@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:M958\|\|Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AMAVATAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Procedure	-	bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म	(Procedure Reference: Vangasena -Bstikarmadhikar-sloke 179-181, Procedure details: Kshara Basti for 16 days daily once before meal in morning)
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Erand Bhrisht Haritaki Churna, Reference: Chakradutta 25/11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushnaudak), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients having their Age more than 18 years. Patients with & without any Deformity were included. Patients having sign & symptoms of Arthritis. Its onset depends upon the lifestyle.

ExclusionCriteria

Details

Patients having severe joint deformities.
Patients having age less than 18 and greater than 70 years
Patient suffering from paralysis.
patient having any type of arthropathy such as neoplasm of spine, gout, ankylosing spondylosis, traumatic arthritis and pyogenic osteomyelitis etc
Patients having associated cardiac disease, tuberculosis, Diabetes mellitus, malignant hypertension, renal function impairment, hypothyroidism, rheumatic heart disease etc
Patients with extremely reduced joint space
Pregnant women and lactating mother
Patient taking disease modifying anti rheumatic drugs(DMARDs) for rheumatoid arthritis

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Relief in signs and symptoms of Amavata i.e Angamarda Aruchi Trushna Aalasya Gaurava Jwara Apaka Sandhishootha Sandhishoola Sandhistambha	45 days

Secondary Outcome

Outcome	TimePoints
Change in RA Factor.	45 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)

14/04/2026

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 a randomized ,open ,parallel-group , interventional prospective trial comparing the efficacy of Kshara Basti and Haritaki Churna in Group A and only Haritaki Churna in Group B in the management of Amavata , that will be conducted in Government Ayurvedic college and Hospital at Patna, Bihar in the Department of Panchkarma. There will be 20 patients in each group and dose of Haritaki Churna will be 5 gm per day at bedtime orally. Study will be conducted for 45 days with follow up at every 15 days. Kshara Basti procedure will be conducted for 16 days once before meal through Ano-rectal route in the dose of 400 ml.