Clinical evaluation of Vyoshadi guggulu with Vaitarana Basti in the management of Amavata (Rheumatoid Arthritis): A Controlled Clinical study.
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1.Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis.
Study Overview
Brief Summary
This study is a Open label Controlled Clinical trial to evaluate the Combined Clinical effect of Vyoshadi Guggulu along with Vaitarana Basti protocol in the Disease Activity of Rheumatoid arthritis. Subjects are allocated in to study and control groups respectively.
Study group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral administration of Tab. Vyoshadi guggulu 500mg TID with lukewarm water After food for 31 days starting from Day-1 of the trial along with Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti which is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period).
Control group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral administration of Tab. Simhanada guggulu 500mg TID with lukewarm water After food for 31 days starting from Day-1 of the trial along with Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti which is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period).
The Primary Outcome measure will be Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis after 31 days.
The Secondary Outcome measure will be QoL- RA (Quality of Life- Rhematoid Arthritis) Questionnaire after 31 days.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American College of Rheumatology/ European League against Rheumatism classification criteria for Rheumatoid Arthritis 2010, Subjects who fulfills a score of greater than or equal to 6/10 with Duration of symptoms greater than or equal to 6 weeks and Lesser than or equal to 10 years.
Exclusion Criteria
- •Subjects, 1.On drug therapy such as DMRAD’s.
- •2.With Severe joint deformity.
- •3.Diagnosed with Spine, Gout, Ankylosing spondylosis, Osteoarthritis, Traumatic arthritis, Psoriatic arthritis, Infective Arthritis, Septic arthritis and Pyogenic Osteomyelitis.
- •4.With associated co-morbidities such as Cardiac disease, Pulmonary Tuberculosis, Uncontrolled Diabetes Mellitus, Malignant Hypertension, Renal Function Impairment.
- •5.Pregnant and Lactating Women.
- •6.Contraindicated for Basthi procedure.
Outcomes
Primary Outcomes
1.Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis.
Time Frame: Day-0 & Day-32
2.Pratyatma Lakshanas Of Amavata.
Time Frame: Day-0 & Day-32
Secondary Outcomes
- QoL- RA (Quality of Life- Rhematoid Arthritis) Questionnaire(Day-0 & Day-32)