A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis

Phase 2UnknownNCT01905735

Healthcare Homoeo Charitable Society60 enrolled

Overview

the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.

it is a multicenter phase 2 ,double blind study in patient with active Rheumatoid arthritis ,there are 2 group in the study A and B ,where group A receive Rhustoxicodendron in 30 potency the first dose will administered orally (1/2 ml)after the completion of case taking ,and repeated every 7th day for 5 month and on the other hand group B receive placebo orally in (1/2 ml) at same interval for same period .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis.

Interventions

Rhustoxicodendron 30DRUG

1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.

placeboDRUG

1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * those who will provide written consent to participate in the study * patient willing to turn up for 7th day follow up * patient who are willing and compliance to the study * those who are between 25 to 60 years . * patient who are willing and compliance to the study . * ESR more then 28 mm. Exclusion Criteria: * Participating as a subject in any other clinical research study. * Children below the age of 25years. * Female subject who are pregnant or planning for pregnancy within 6 month. * History of seizures * Breast feeding women's. * Patient on treatment for life threatening illness like cancer aids etc. * Patient should not have any congenital abnormality or patient should not have undergone any operative procedure as consequences of RA.

Locations (2)

Gupta Homoeo Clinic

Delhi, National Capital Territory of Delhi, India

RECRUITING

Kochhar Clinic

Ludhiana, Punjab, India

RECRUITING

Outcomes

Primary Outcomes

Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).

number of subject with ACR criteria improvement consisting of ACR 20,ACR50,ACR70 reduction in tender and swollen joint counts and 20%,50%,70% improvement respectively in 3 of the following 5 criteria . 1. physician global assessment of disease activity's. 2. patient global assessment of disease activity's. 3. subject assessment of pain 4. subject assessment of function disability via health assessment questionnaire\[HAQ\] 5. acute phase reactant ESR every 6 weeks upto 24 week