Trial record 16 of 18 for:    Open Studies | homeopathy

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

This study is currently recruiting participants.
Verified August 2013 by Healthcare Homoeo Charitable Society
Sponsor:
Information provided by (Responsible Party):
ravinder kochhar, Healthcare Homoeo Charitable Society
ClinicalTrials.gov Identifier:
NCT01905735
First received: July 19, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis.
Drug: Rhustoxicodendron 30
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 .

Resource links provided by NLM:


Further study details as provided by Healthcare Homoeo Charitable Society:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • mean change from baseline in tender joint count. [ Time Frame: 6 weeks upto 24 week ] [ Designated as safety issue: No ]
  • mean change from baseline in swollen joint. [ Time Frame: 6 weeks upto 24 week ] [ Designated as safety issue: No ]
  • mean change from baseline in physician global assessment of disease activity. [ Time Frame: every 6 weeks upto 24 week ] [ Designated as safety issue: No ]
    mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm)

  • mean change from baseline in patient global assessment of disease . [ Time Frame: 6 weeks upto 24 week ] [ Designated as safety issue: No ]
    mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm)

  • mean change from baseline in subject assessment of pain using VAS from 0-100 mm [ Time Frame: 6 weeks upto 24 week ] [ Designated as safety issue: No ]
  • mean change from baseline in ESR [ Time Frame: 6 weeks upto 24 week ] [ Designated as safety issue: No ]
  • mean change from baseline in disability index of the health assessment Questionnaire (HAQ) [ Time Frame: 6 weeks upto 24 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: poison ivy

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

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905735

Contacts
Contact: seenia sharma, B.H.M.S 0091-7837144332 drseeniasharma@gmail.com
Contact: mukesh k singh, B.H.M.S 0091-9463131239 drmukeshkrsingh@gmail.com

Locations
India
Kochhar Clinic Recruiting
Ludhiana, Punjab, India, 141001
Contact: seenia sharma, B.H.M.S    0091-7837144332    drseeniasharma@gmail.com   
Contact: mukesh k singh, B.H.M.S    0091-9463131239    drmukeshkrsingh@gmail.com   
Sub-Investigator: seenia sharma, B.H.M.S         
Sub-Investigator: kuljinder kaur, B.H.M.S         
Gupta Homoeo Clinic Recruiting
Delhi, India
Contact: mohit gupta, B.H.M.S    0091-9212580805    dr.mohitgupta@yahoo.in   
Sub-Investigator: mohit gupta, B.H.M.S         
Sub-Investigator: bhuwnesh goyal, B.A.M.S         
Sub-Investigator: prateek singh, B.H.M.S         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: ravinder kochhar, principal investigator, Healthcare Homoeo Charitable Society
ClinicalTrials.gov Identifier: NCT01905735     History of Changes
Other Study ID Numbers: SLSGB-01
Study First Received: July 19, 2013
Last Updated: August 1, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Healthcare Homoeo Charitable Society:
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014