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Clinical Trials/CTRI/2024/04/066070
CTRI/2024/04/066070CompletedPhase 3

Efficacy of virechana followed by bodhi kashaya yoga basti and virechana followed by bodhi kashaya pana in the management of vatarakta w.s.r. to gout - An open labelled randomized comparative clinical trial.

Institute of Teaching and Research in Ayurveda Jamnagar1 site in 1 country30 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Relief in pain swelling and redness

Study Overview

Brief Summary

Introduction:

Vatarakta is a metabolic disorder in which vitiated Vata circulates through Srotas, and already Dushit rakta obstructs Vata and again agitate Vata, which further leads to Vatarakta. Here, in the present study considering Gout will be taken for the study. Initial symptoms usually consist of intense episodes of painful swelling in single joint.

As per Ayurveda, disease occurs due to aggravation of Vata along with Rakta resulting obstruction in metabolic pathways leading to the joint pain, restriction in movement and joint swelling etc. In the classics; Virechana karma and Basti karma are specially indicated in Bahudosha Avastha as a curative measure.

Significance:

2015-2016 worldwide the prevalence of gout was 3.9% among adults with 5.2% in men and 2.7% in women. This prevalence has been doubled since 1990s According to above data, it becomes a great concern how to deal with Gout and treat properly. Modern science is using quick acting NSAIDS & uricosuric to treat which have control over joint pain but have potential adverse effect.Only few number of research works are done on Vatarakta. Hence, an attempt has been made here to study Efficacy of Virechana followed by Bodhi Kashaya Yoga Basti and Virechana followed by Bodhi Kashaya pana in the management of Vatarakta w.s.r to Gout.

Aim & Objectives:

To evaluate and compare the efficacy Of Virechana followed by Bodhi Kashaya Yoga Basti and Virechana followed by Bodhi Kashaya Pana in the management of Vatarakta w.s.r. to Gout.

Materials and Methods:

30 Diagnosed or newly Diagnosed pt of Gout will be enrolled in two groups. Group A patients will receive intervention with Virechana with Aragwadha phala majja and Eranda taila followed by Yoga Basti with Bodhi kashaya Yastimadhwadi taila.Group B patients will receive Virechana with Aragwadha phala majja and Eranda taila followed by Bodhi kashaya Pana with Madhu.

Results and Discussion:

Data generated during the above study will be present in a Systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Follow up: After completion of therapy, follow up will be done after 30 day to assess the status of patient, where patient will be asked to report.

Adverse effects:

This drug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients of either sex.
  • •Diagnosed patients of gout.
  • •Patients Yogya for Basti karma and Virechana.

Exclusion Criteria

  • •Patient having uncontrolled systemic diseases like HTN, DM, RA, active neoplastic disease, ulceration, progressive gangrenous changes and any other autoimmune diseases like Rheumatoid arthritis, SLE etc will be excluded.
  • •Pregnancy, lactation.
  • •Patients Ayogya for Basti karma and Virechana karma.

Outcomes

Primary Outcomes

Relief in pain swelling and redness

Time Frame: 8 days for both A & B groups

Secondary Outcomes

  • changes in serum uric acid level(8 days for both A & B groups)

Investigators

Sponsor
Institute of Teaching and Research in Ayurveda Jamnagar
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Rakesh Kumar Majhi

Institute of Teaching and Research in Ayurveda, Jamnagar

Study Sites (1)

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