A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
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 .
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Aug 2013
Shorter than P25 for phase_2 rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
July 23, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedAugust 2, 2013
August 1, 2013
5 months
July 19, 2013
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 weeks upto 24 week
Secondary Outcomes (7)
mean change from baseline in tender joint count.
6 weeks upto 24 week
mean change from baseline in swollen joint.
6 weeks upto 24 week
mean change from baseline in physician global assessment of disease activity.
every 6 weeks upto 24 week
mean change from baseline in patient global assessment of disease .
6 weeks upto 24 week
mean change from baseline in subject assessment of pain using VAS from 0-100 mm
6 weeks upto 24 week
- +2 more secondary outcomes
Study Arms (2)
placebo
PLACEBO COMPARATOR1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .
Rhustoxicodendron 30
ACTIVE COMPARATOR1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Interventions
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Gupta Homoeo Clinic
Delhi, National Capital Territory of Delhi, India
Kochhar Clinic
Ludhiana, Punjab, 141001, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ravinder kochhar, MD hom
Healthcare Homoeo Charitable Society
- STUDY DIRECTOR
mukesh k singh, B.H.M.S
health care homoeo charitable society
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
July 19, 2013
First Posted
July 23, 2013
Study Start
August 1, 2013
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
August 2, 2013
Record last verified: 2013-08