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

August 1, 2013 updated by: ravinder kochhar, Healthcare Homoeo Charitable Society

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 .

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India
        • Recruiting
        • Gupta Homoeo Clinic
        • Contact:
        • Sub-Investigator:
          • mohit gupta, B.H.M.S
        • Sub-Investigator:
          • bhuwnesh goyal, B.A.M.S
        • Sub-Investigator:
          • prateek singh, B.H.M.S
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Recruiting
        • Kochhar Clinic
        • Contact:
        • Contact:
        • Sub-Investigator:
          • seenia sharma, B.H.M.S
        • Sub-Investigator:
          • kuljinder kaur, B.H.M.S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .
Drug: placebo
1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.
Other Names:
  • dispensing alcohol
Active Comparator: Rhustoxicodendron 30
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Drug: Rhustoxicodendron 30
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Other Names:
  • poison ivy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
Time Frame: 6 weeks upto 24 week

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean change from baseline in tender joint count.
Time Frame: 6 weeks upto 24 week
6 weeks upto 24 week
mean change from baseline in swollen joint.
Time Frame: 6 weeks upto 24 week
6 weeks upto 24 week
mean change from baseline in physician global assessment of disease activity.
Time Frame: every 6 weeks upto 24 week
mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm)
every 6 weeks upto 24 week
mean change from baseline in patient global assessment of disease .
Time Frame: 6 weeks upto 24 week
mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm)
6 weeks upto 24 week
mean change from baseline in subject assessment of pain using VAS from 0-100 mm
Time Frame: 6 weeks upto 24 week
6 weeks upto 24 week
mean change from baseline in ESR
Time Frame: 6 weeks upto 24 week
6 weeks upto 24 week
mean change from baseline in disability index of the health assessment Questionnaire (HAQ)
Time Frame: 6 weeks upto 24 week
6 weeks upto 24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthcare Homoeo Charitable Society

Investigators

  • Principal Investigator: ravinder kochhar, MD hom, Healthcare Homoeo Charitable Society
  • Study Director: mukesh k singh, B.H.M.S, health care homoeo charitable society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLSGB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis.

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe