Evaluation of effect of Shallaki, Lepa and Janu Vasti in Patients With Knee Joint Osteoarthritis

Phase 2

Not yet recruiting

• Conditions: Bilateral primary osteoarthritis of knee. Ayurveda Condition: Janusandhigata Vata,

• Registration Number: CTRI/2021/04/032807
• Lead Sponsor: National Institute of Ayurvea

Brief Summary

This study is a randomized, open label, parallel group, single centre, comparative clinical trial evaluating effect of *Shallaki* and its comparative synergistic effect with *Lepa* and *Janu Vasti* in *Janusandhigata Vata* with special reference to Knee joint Osteoarthritis. Null hypothesis of the study is there is no difference in the treatment outcome of *Janusandhigata Vata* with special reference to knee joint osteoarthritis when treated with three different interventions of *Shallaki,* *Shallaki* with *Koladi Lepa* or *Shallak*i with *Ketakyadi Janu Vasti*. *Shallaki* will be given 1 gram thrice a day for 15 days in one group and other group will be treated with *shallaki* 1 gram thrice a day with external application of 30 grams of *Koladi Lepa* twice a day for 15 days. Third group will be treated with *Shallaki* 1 gram thrice a day and Janu Vasti with *Ketakyadi Taila* (250 ml) once a day for 15 days. Site of study will be National Institute of Ayurveda, Jaipur, Rajasthan, India. Primary outcome of the study is reduction of pain and stiffness including sign and symptoms of Janusandhigata Vata of *Shota* (edema), *Vatapurnadriti Sparsha* ( on palpation revealed as air filled bag) and pain with *Prasarana* and *Akunchana*( extension and flexion) and improvement in Knee injury and osteoarthritis outcome score ( KOOS). Secondary outcome of the study is improvement in the range of motion.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-26
• Study Start: 2021-06-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 1.Patients in the age group of 40 to 70 years of either sex.
• 2.Patients having signs and symptoms of Janusandhigata Vata of Shotha (edema), Vatapurnadriti Sparsha (on palpation revealed as air filled bag) and pain with Prasaran (extension) and Akunchan (flexion) movements.
• 3.Patients having chronicity of disease Janusandhigata Vata (KOA) for less than 5 years.
• 4.Patients willing to sign consent form for the clinical trial.
• 5.Kellgren Lawrence (Radiological scale) of e†≥2.

Exclusion Criteria

• 1.Patients below 40 years and above 70 years of age.
• 2.Patients of Rheumatoid arthritis, Ankylosing and traumatic arthritis.
• 3.Patients suffering from paralysis, muscular dystrophy, polio affected persons or persons with bony deformities 4.Patients having systemic conditions such as Tuberculosis, Brucellosis, Osteomyelitis, Gouty Arthritis, Psoriatic Arthritis and Systemic Lupus Erythematosus 5.Patients having neoplasm of spine and other complicated diseases like CCF, DM, Uncontrolled HTN, Unstable Angina, Recent MI etc.
• 6.Patients using anti-inflammatory medicines including Allopathic medicine and AYUSH medicines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in pain and stiffness	15 days
including signs and symptoms of Janusandhigata Vata of Shotha (edema), Vatapurnadriti Sparsha (on palpation revealed as air filled bag) and pain with Prasaran (extension), Akunchan (flexion) movements and improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS)	15 days

Secondary Outcome Measures

Name	Time	Method
Improvement of range of motion	15 days

Trial Locations

Locations (1)

National Institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr A M H S Attanayake

Principal investigator

9119218397

harshamed@yahoo.com