Homeopathic Clinical Research

PROTOCOL

A SINGLE BLINDED PILOT STUDY, BALANCED, RANDOMIZED, PLACEBO CONTROL, PARALLEL ASSIGNMENT, TO EVALUATE THE EFFICACY STUDY OF CONSTITUTIONAL REMEDY IIN OSTEOARTHRITIS HIP OR KNEE.


Objective:
Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at 84 weeks
&
Change from baseline in the WOMAC Osteoarthritis Index pain subscale score at 22 weeks.

Investigational Products:
Test product-A
(Constitutional remedy)
(Homeopathically prepared medicine)

Test Product-B
Placebo (Sugar of milk)

Dose:
30 potency 6 doses in two intervals.


Wash-out period:
At least 7 days, but not exceeding 10 days before participating in the study. The Subject should be withdrawn from all the medications.


Clinical Safety Measurements:

A physician will be available within the clinical facility. A consultant physician will be always available on call during the study period.
Subjects should meet the criteria for enrolment in the study.
Screening of the subjects will be done on Day-10.
Screening will include clinical examinations of the subjects including-




1.General physical examination.
2.Vital signs and oral body temperature.
3.Sitting blood pressure and radial pulse.
4.X-ray of the affected joint.
5.Blood routine
6.Questions will be asked according to the WOMAC OSTEOARTHRITIS INDEX.
7.Assessment of the well being of the subjects at the time of clinical examination.

Subjects selected from the screening will be randomized at the base-line study on day 0. Following randomization, the subjects will be will be assessed for
1.General physical examination.
2.Vital signs and oral body temperature.
3.Sitting blood pressure and radial pulse.
4.Well being.
5.WOMAC OA INDEX.
6.A complete homoeopathic case taking of the subjects will be done.

The subjects will go through following examination in all visits except visit 3rd and visit 14th .

1.General physical examination
2.well being
3.vital signs
4.Blood pressure and radial pulse.
On the 14 th visit , at the end of the study, the subjects will be again assessed for
1.General physical examination.
2.vital signs and oral body temp
3.Sitting blood pressure and radial pulse.
4.X-ray of the affected joint.
5.Blood routine.
6.ECG.
7.well being
8.WOMAC OA INDEX.
The study will commence only after a written approval is obtained from the Independent Ethics Committee.
The trial will be conducted as per the ICMR Ethical Guidelines for Biomedical Research on Human Subjects (2006), ICH-GCP Guidelines and in accordance with the Declaration of Helsinki (Tokyo 2004).
Primary Efficacy End Points:
Following the randomization the subjects will be dosed with treatment A or B. In this first interval the subjects will be dosed 3 times in 14 days interval (3-5 visits). Following the first interval the subjects will be observed for efficacy and safety assessment for (6-8 visit).
Secondary Efficacy End Points:
In this first interval the subjects will be dosed 3 times in 14 days interval (9-11 visits). Following the 2nd interval the subjects will be observed for efficacy and safety assessment for (12-14 visits).
Safety assessment:
If subjects Womac OA score increase beyond the baseline score or remain in same score following 1 st interval dosing. Those subjects will be changed to rescue therapy. (the rescue medication will be prescribed by medical expert as per the requirement)

Category:

Science & Technology

Tags:

• Osteoarthritis
• clinical research
• design your study
• homeopathy
• protocol writing
• medical writing
• homoeopathy
• research consultant
• dentist
• hospital
• surgery
• treatment
• homeopathic