Study to Test the Effect of Lakshadi Guggulu with Physiotherapy in People with Knee Joint Pain (Osteoarthritis)

Phase 2

Not yet recruiting

Conditions: Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,

Brief Summary: This study aims to evaluate the effectiveness of Lakshadi Guggulu combined with physiotherapy in managing knee osteoarthritis (Sandhigata Vata) compared to a placebo with physiotherapy. The research will involve patients aged 40-70 with symptomatic knee osteoarthritis. The treatment will be assessed using subjective measures like pain, swelling, stiffness, and joint mobility using Visual Analog Scale (VAS) and WOMAC scores. The study design is a randomized double-blind placebo-controlled trial, with 78 participants divided into two groups. The treatment will last 60 days with follow-up assessments at 15, 30, 45, and 60 days. The study will include statistical analysis using SPSS, and ethical clearance will be obtained from the Institutional Ethics Committee. The primary focus is on evaluating the combination of Lakshadi Guggulu and physiotherapy for long-term relief and improving patient quality of life.

Recruitment & Eligibility

Inclusion Criteria

Patients showing symptoms of sandhi Gata Vata of Janu Sandhi 2.
Patient having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g. walking, standing, climbing staircase) during the preceding 24 hours 3.
Morning stiffness less than 30 min.
Patients willing to follow up.
Patients willing to give written informed consent.

Exclusion Criteria

Patients with known case of gout, rheumatoid arthritis, psoriatic arthritis, septic arthritis, and congenital joint anomalies.
2.Patients with history of rickets, osteomalacia.
3.Participants with history of auto-immune disease, uncontrolled hypertension, chronic severe respiratory disease History of life threatening cardiovascular and /or neurological event in the past one year 4.Morning stiffness more than 30 min.

Primary Outcome Measures

Name	Time	Method
To study the effect of Lakshadi Guggulu with Physiotherapy in comparison with Placebo with Physiotherapy on the basis of subjective parameters like Joint pain, swelling, stiffness, difficulty in movements using VAS (Visual Analog Scale)	0,15,30,45,60th day

Secondary Outcome Measures

Name	Time	Method
To study the effect of Lakshadi Guggulu with physiotherapy versus placebo with physiotherapy on the basis of WOMAC total score and subscore.	0,15,30,45,60th Day
To study the effect of Lakshadi Guggulu with physiotherapy versus placebo with physiotherapy on the basis of requirement of rescue medicines in term of dose, frequency and duration in either group from baseline till end of the study.

Locations (1): Khemdas Hospital
🇮🇳
Vadodara, GUJARAT, India
Khemdas Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Mansi Deore
Principal investigator
9588602572
mansideore66@gmail.com