Back to resultsA Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis.
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Rhustoxicodendron 30
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis. focused on measuring RA
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.
Sites / Locations
- Kochhar ClinicRecruiting
- Gupta Homoeo ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
Rhustoxicodendron 30
Arm Description
1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Outcomes
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).
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 .
physician global assessment of disease activity's.
patient global assessment of disease activity's.
subject assessment of pain
subject assessment of function disability via health assessment questionnaire[HAQ]
acute phase reactant ESR every 6 weeks upto 24 week
Secondary Outcome Measures
mean change from baseline in tender joint count.
mean change from baseline in swollen joint.
mean change from baseline in physician global assessment of disease activity.
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 .
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
mean change from baseline in ESR
mean change from baseline in disability index of the health assessment Questionnaire (HAQ)
Full Information
NCT ID
NCT01905735
First Posted
July 19, 2013
Last Updated
August 1, 2013
Sponsor
Healthcare Homoeo Charitable Society
1. Study Identification
Unique Protocol Identification Number
NCT01905735
Brief Title
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
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Healthcare Homoeo Charitable Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis.
Keywords
RA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .
Arm Title
Rhustoxicodendron 30
Arm Type
Active Comparator
Arm Description
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Intervention Type
Drug
Intervention Name(s)
Rhustoxicodendron 30
Other Intervention Name(s)
poison ivy
Intervention Description
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
dispensing alcohol
Intervention Description
1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.
Primary Outcome Measure Information:
Title
Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
Description
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 .
physician global assessment of disease activity's.
patient global assessment of disease activity's.
subject assessment of pain
subject assessment of function disability via health assessment questionnaire[HAQ]
acute phase reactant ESR every 6 weeks upto 24 week
Time Frame
6 weeks upto 24 week
Secondary Outcome Measure Information:
Title
mean change from baseline in tender joint count.
Time Frame
6 weeks upto 24 week
Title
mean change from baseline in swollen joint.
Time Frame
6 weeks upto 24 week
Title
mean change from baseline in physician global assessment of disease activity.
Description
mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm)
Time Frame
every 6 weeks upto 24 week
Title
mean change from baseline in patient global assessment of disease .
Description
mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm)
Time Frame
6 weeks upto 24 week
Title
mean change from baseline in subject assessment of pain using VAS from 0-100 mm
Time Frame
6 weeks upto 24 week
Title
mean change from baseline in ESR
Time Frame
6 weeks upto 24 week
Title
mean change from baseline in disability index of the health assessment Questionnaire (HAQ)
Time Frame
6 weeks upto 24 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
seenia sharma, B.H.M.S
Phone
0091-7837144332
Email
drseeniasharma@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mukesh k singh, B.H.M.S
Phone
0091-9463131239
Email
drmukeshkrsingh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ravinder kochhar, MD hom
Organizational Affiliation
Healthcare Homoeo Charitable Society
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
mukesh k singh, B.H.M.S
Organizational Affiliation
health care homoeo charitable society
Official's Role
Study Director
Facility Information:
Facility Name
Kochhar Clinic
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
seenia sharma, B.H.M.S
Phone
0091-7837144332
Email
drseeniasharma@gmail.com
First Name & Middle Initial & Last Name & Degree
mukesh k singh, B.H.M.S
Phone
0091-9463131239
Email
drmukeshkrsingh@gmail.com
First Name & Middle Initial & Last Name & Degree
seenia sharma, B.H.M.S
First Name & Middle Initial & Last Name & Degree
kuljinder kaur, B.H.M.S
Facility Name
Gupta Homoeo Clinic
City
Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohit gupta, B.H.M.S
Phone
0091-9212580805
Email
dr.mohitgupta@yahoo.in
First Name & Middle Initial & Last Name & Degree
mohit gupta, B.H.M.S
First Name & Middle Initial & Last Name & Degree
bhuwnesh goyal, B.A.M.S
First Name & Middle Initial & Last Name & Degree
prateek singh, B.H.M.S
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
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