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Clinical Trials/CTRI/2024/11/076126
CTRI/2024/11/076126Not yet recruitingPhase 2/3

Role of Agnimandya in Nidana Evum Samprati of Amavata with special reference to rheumatoid arthritis and its comparative Upshayatmaka Parikshana by Rasonadi Kashaya and Kulattha Yusha.

Government Ayurvedic P G College And Hospital Chaukaghat Varanasi1 site in 1 country60 target enrollmentStarted: November 5, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Rasonadi kashaya and kulattha yusha help in relieving the Symptoms of agnimandya and also in symptoms of Amavata .

Study Overview

Brief Summary

Objective: To compare the effectiveness of Rasonadi kashaya and Kulattha yusha in treating Amavata and investigate the role of Agnimandya in the disease process.

Participants: 60 Adults diagnosed with Amavata meeting inclusion and exclusion criteria from OPD and IPD of department of Rog nidan Evum Vikriti Vigyana and Department of Kayachikitsa of Government PG Ayurvedic Medical College and Hospital Chaukaghat, Varanasi.

Interventions:

30 patients  -Rasonadi Kashaya: Administered according to a standardized protocol.

30 patients -   Kulattha Yusha:    Administered according to a standardized protocol.

Primary Outcome: 1)Rasonadi kashaya and kulattha yusha help in relieving the Symptoms of agnimandya and also in symptoms of Amavata .

Secondary Outcomes:1)Significant relief in symptoms of amavata and also any adverse events experienced by participants.

2)It also helps in improving the quality of life in amavata patients.

Follow up -15 Days

Time Period: 1 month

Data Analysis: Data will be analyzed using appropriate statistical methods to compare the effectiveness of the interventions on the primary and secondary outcomes.

Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participants.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
16.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient having sign and symptoms of Amavata will considered for the present study.
  • Patients of 16-60 years of age.
  • Patients of either sex.
  • Patient either married and unmarried.
  • Chronicity of less than 10 years.
  • Patient who has satisfied the criteria laid down by the American Rheumatisın Association will be selected and registered for detailed investigation and follow up Patient has to satisfied atleast 4 of these 7 criteria.

Exclusion Criteria

  • Complicated cases of R.A, associated with DM & HTΝ.
  • Patients suffering from Carcinoma, Systemic diseases like- Chronic Renal disease, Heart/Hepatic disease, HIV & other immune compromised diseases.
  • Pregnant and lactating mothers.
  • Severe deformities with severe ankylosed joints, Patients of R.A with chronicity of more than 10 years.
  • Patients below 16 years and above 60 years.

Outcomes

Primary Outcomes

Rasonadi kashaya and kulattha yusha help in relieving the Symptoms of agnimandya and also in symptoms of Amavata .

Time Frame: 30 Days

Secondary Outcomes

  • Significant relief in symptoms of amavata and also any adverse events experienced by participants.(It also helps in improving the quality of life in amavata patients.)

Investigators

Sponsor
Government Ayurvedic P G College And Hospital Chaukaghat Varanasi
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Joshi Sonal Ram

Government Ayurvedic P.G.College And Hospital Chaukaghat Varanasi

Study Sites (1)

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