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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01905735
Recruitment Status : Unknown
Verified August 2013 by ravinder kochhar, Healthcare Homoeo Charitable Society.
Recruitment status was:  Recruiting
First Posted : July 23, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
ravinder kochhar, Healthcare Homoeo Charitable Society

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis. Drug: Rhustoxicodendron 30 Drug: placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 .
Study Start Date : August 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. mean change from baseline in tender joint count. [ Time Frame: 6 weeks upto 24 week ]
  2. mean change from baseline in swollen joint. [ Time Frame: 6 weeks upto 24 week ]
  3. 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)

  4. 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)

  5. mean change from baseline in subject assessment of pain using VAS from 0-100 mm [ Time Frame: 6 weeks upto 24 week ]
  6. mean change from baseline in ESR [ Time Frame: 6 weeks upto 24 week ]
  7. mean change from baseline in disability index of the health assessment Questionnaire (HAQ) [ Time Frame: 6 weeks upto 24 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ravinder kochhar, principal investigator, Healthcare Homoeo Charitable Society
ClinicalTrials.gov Identifier: NCT01905735     History of Changes
Other Study ID Numbers: SLSGB-01
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013

Keywords provided by ravinder kochhar, 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
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs