Clinical trial NCT01905735: A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
Official title: A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis.
Keywords: RA
Lead sponsor: Healthcare Homoeo Charitable Society
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
timeFrame: 6 weeks upto 24 week
Secondary outcomes:
measure: mean change from baseline in tender joint count.
timeFrame: 6 weeks upto 24 week
measure: mean change from baseline in swollen joint.
timeFrame: 6 weeks upto 24 week
measure: mean change from baseline in physician global assessment of disease activity.
timeFrame: every 6 weeks upto 24 week
measure: mean change from baseline in patient global assessment of disease .
timeFrame: 6 weeks upto 24 week
measure: mean change from baseline in subject assessment of pain using VAS from 0-100 mm
timeFrame: 6 weeks upto 24 week
measure: mean change from baseline in ESR
timeFrame: 6 weeks upto 24 week
measure: mean change from baseline in disability index of the health assessment Questionnaire (HAQ)
timeFrame: 6 weeks upto 24 week
Other outcomes:
Locations:
city: Ludhiana
country: India
facility: Kochhar Clinic
state: Punjab
city: Delhi
country: India
facility: Gupta Homoeo Clinic
Study officials:
affiliation: Healthcare Homoeo Charitable Society
name: ravinder kochhar, MD hom
role: PRINCIPAL_INVESTIGATOR
affiliation: health care homoeo charitable society
name: mukesh k singh, B.H.M.S
role: STUDY_DIRECTOR
References: