An open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of siddhar yoga maruthuva muraigal and siddha medicine AVURI ILAI KUDINEER in the management of AZHAL KEEL VAYU
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The outcome of the study will be assessed by using the Universal Pain assessment scale
Study Overview
Brief Summary
The study isAN OPEN LABELED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL, TO EVALUATE THE EFFICACY OF SIDDHAR YOGA MARUTHUVA MURAIGAL AND SIDDHA MEDICINE "AVURI ILAI KUDINEER[INTERNAL]†IN THE MANAGEMENT OF AZHAL KEEL VAYU â€. The trial drug will be administrated at the dose of 30ml/ twice a day A/F 48 days in 40 patients. The trial period of 12 months will be carrying out
in Government Siddha Medical College & Hospital, Palayamkottai, Tirunelveli, Tamil Nadu. ThePrimary Outcome:
The study aims at bringing light on the Efficacy of the long standing traditional practice of Siddhar yogam therapy towards the management of Azhal keel vayu.
It is expected that Siddhar yogam therapy along with AVURI illai kudineer will produce expected results in managing the problem of Azhal keel vayu.
Secondary Outcome:
The positive impact of Yoga in the treatment aspect may be highlighted through this study . In case of any adverse event (AE) is noticed and it will be referred to
pharmacovigilance department of SCRI. Further management of patient will be given in OPD
facility.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 35.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient having the symptoms of joint pain in one or both knee joints swelling tenderness stiffness crepitation restricted movement of joints Patients who are willing to give radiological investigation and provide blood for lab investigation Patients who are willing to participate in this study with the knowledge of potential risks and who are willing to sign the informed consent form.
Exclusion Criteria
- •â€¢ Rheumatoid arthritis •cardiac disease history of trauma carcinoma Tuberculosis Patients with any other serious illness Pregnancy women and lactating mothers.
Outcomes
Primary Outcomes
The outcome of the study will be assessed by using the Universal Pain assessment scale
Time Frame: 48 days
(before and after treatment)
Time Frame: 48 days
Secondary Outcomes
- •The positive impact of Yoga in the treatment aspect may be highlighted through this study.(48days)