A study to fine efficacy of two Ayurvedic drugs in the treatment of pain and swelling of joints occurring after chikungunya fever.

Phase 3

Completed

• Conditions: Chikungunya virus disease,

• Registration Number: CTRI/2019/02/017659
• Lead Sponsor: Institute for Post Graduate Teaching and Research in Ayurveda

Brief Summary

This study was a randomized clinical trial to evaluate the effect of  Punarnava Guggulu and Sanjivani Vati in the management of post chikunguya chronic inflammatory rheumatism. Total 32 patients were enrolled in present study. Selected patients were divided in two group on the basis of computer generated randomisation. In this study Punarnava Guggulu was given in dose 2 tablet (300 mg each) tds after food with warm water for 2 months and Sanjivni Vati was 2 tablet (125mg each) tds after food with warm water for 2 months,  Patients of both the group were also given two sitting of Sarvanga Vashpa Swedana, each sitting of 6 days in the morning with Dashmulakwathaduring initial two week of  treatment.   Patients were allowed to use concomitant drugs during the course of trial.   Follow up will be carried out at 7 days interval for 1 month . Assessment was made on the basis of subjective criteria like chief complaints and associated complaints and objective criteria like ESR, CRP(Quantitative), VAS score, RAPID3 score and disability index. after applying statistical test highly significant improvement was found in both the group in subjective criteria. In objective criteria, statistically significant decrease was found in both the groups. by comparing two groups, statistically insignificant difference was found. Thus alernative hypothesis is rejected and null hypothesis i.e. "Punarnava Guggulu and Sanjivani Vati are effective in the management of post chikungunya chronic inflammatory rheumatism when given orally along with Sarvanga Vashpa Swedana". No any adverse drug reaction was found in both of the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-18
• Study Completion: 2020-01-23
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Confirm case of Chikungunya fever with symptoms of pCHIK-CIR.
• 2.Patient willing to participate in the trial.

Exclusion Criteria

• 1.Age below 18 years & above 60 years.
• 2.Pregnant and lactating women 3.
• History of RA, Gout, Psoriatic arthritis, rheumatic fever, autoimmune disease, thyroid dysfunction, sarcoidosis, SLE before Chikungunya fever.
• 4.Patients suffering from: Malignant and accelerated hypertension, coronary artery disease, uncontrolled diabetes.
• •Patient undergoing regular treatment for any other severe illness and also patients suffering from pulmonary tuberculosis, bone tuberculosis, carcinoma and HIV positive patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy	2 months

Secondary Outcome Measures

Name	Time	Method
safety	2 months

Trial Locations

Locations (1)

IPGT and RA hospitle; 🇮🇳 Jamnagar, GUJARAT, India

IPGT and RA hospitle

🇮🇳Jamnagar, GUJARAT, India

chaitali kakadiya

Principal investigator

7046214241

chaitali.kakadiya@yahoo.com