跳至主要内容
临床试验/CTRI/2019/02/017659
CTRI/2019/02/017659已完成3 期

Efficacy of Punarnava Guggulu and Sanjivani Vati in the management of Post Chikungunya Chronic Inflammatory Rheumatism -An Open Labelled Randomized Comparative Clinical Trial

Institute for Post Graduate Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月18日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
efficacy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 1.Age below 18 years & above 60 years.
  • 2.Pregnant and lactating women
  • 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.

结局指标

主要结局

efficacy

时间窗: 2 months

次要结局

  • safety(2 months)

研究者

发起方
Institute for Post Graduate Teaching and Research in Ayurveda
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验

A study to fine efficacy of two Ayurvedic drugs in... | 临床试验