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临床试验/CTRI/2011/10/002058
CTRI/2011/10/002058招募中2 期

A PILOT STUDY TO EVALUATE THE THERAPEUTIC EFFICACY OF SIDDHA HERBO MINERAL FORMULATION RAJA LOGA NATHA RASA PARPAM INTERNAL and AATTHIRADHI THAILAM EXTERNAL IN UTHIRAVATHASURONITHAM RHEUMATOID ARTHRITIS

NATIONAL INSTITUTE OF SIDDHA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月18日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Pain is assessed by Universal pain assessment scale.

研究概览

简要总结

This study is a single arm trial to evaluate the efficacy of siddha herbo mineral formulation Raja Loga Natha Rasa Parpam - internal drug 250mgs twice a day with pepper powder and ghee along with Aathiradhi thailam - External drug also given as nasal drops (Nasiyam) in Rheumatoid arthiritis (Uthiravadha suronitham).The internal drug consists of rasam(purifiedmercury),Gandhagam(purified sulphur),Sangu(conch shell) and Palagarai(marine shell).The external drug consists of sesame oil,gadi(Vineger),Thayir thelivu( supernatent of curd),Adhimadhuram,Indhuppu,Inji,Chukku,Aanai thippili and Vaai vidangam.The internal drug is selected from the text Prana Rakshamirdha Sindhu and External drug is taken from the text **Agasthiyar Vaidhya Chinthamani ( authenticated text books for siddha medicine).**There has been no clinical trial carried out till today with the above mentioned drugs.Hence the investigator proposed this trial.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

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

入选标准

  • •Symmetrical joint involvement •Arthritis of 3 or more joints •Rheumatoid factor positive or negative •Morning stiffness.
  • •Swelling especially in the inter-phalangeal joint.
  • •Patients who are willing for admission and stay in IPD for 48 days or willing to attend OPD.

排除标准

  • •Hypertension and other Cardiac ailments •Diabetes mellitus •Narcotics •Alcoholics and smokers.
  • •Pregnancy and lactation •History of trauma •Neurological disorder •Tuberculosis •Any other serious illness •Psoriatic arthritis •Gouty arthritis.

结局指标

主要结局

Pain is assessed by Universal pain assessment scale.

时间窗: 0th day and 49th day

The outcome is aimed at reducing the pain and restricted joint movements.

时间窗: 0th day and 49th day

次要结局

  • ESR,RA factor,CRP(0TH AND 49TH DAY)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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