To Check The Efficacy of Janu Basti in cases of Knee Joint Pain.
- Conditions
- Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,
- Registration Number
- CTRI/2025/04/085052
- Lead Sponsor
- State Ayurvedic College and Hospital, Lucknow
- Brief Summary
The Present Synopsis Entitled “A study to evaluate the efficacy of Janu Basti as an add therapy to whole system ayurveda in cases of knee osteoarthritis; a randomized placebo controlled trial.”
AIM OF STUDY
AIM: To find out additional benefits of Janu Basti with medicated oil in comparison to placebo oil on the patients of Janugata Sandhivata (Knee Osteoarthritis).
OBJECTIVES
Primary objective: To evaluate the enhanced benefits of Janu Basti with medicated oil in comparison to placebo oil with whole system ayurveda intervention in janugata sandhivata.
Secondary objective:
To assess the cost of procedure.
To develop a standard operating procedure (SOP).
To study the adversity of procedure.
To study the compliance of procedure.
PLAN OF STUDY
SELECTION OF CASES
For the purpose of clinical trial, the patients of janugata sandhivata / knee O.A will be selected regardless of sex with will be selected randomly from O.P.D, I.P.D and Advanced Arthritis Research Clinic at state ayurvedic college and hospital, Lucknow and also the referred cases which fulfil the criteria who have not taken prior ayurvedic treatment.
A careful history, physical examination and necessary investigation will be performed as Performa prepared for the present trial.
Type of study - Two arm parallel randomized controlled study.
SAMPLE SIZE
Minimum 60 patients with approximately 10% of dropouts of janugata sandhivata from OPD, IPD and advance arthritis research Centre at SAC & H will be selected & divided into two groups with the help of computer-generated random table.
Group A – In this group patients will be treated with whole system of ayurveda and janu basti with active medicated oil ( Bala aswagandhadi oil)
Group B – In this group patients will be treated with whole system of ayurveda and janu basti with placebo control oil (Til tail)
SELECTION OF CASES
For the purpose of clinical trial, the patients of janugata sandhivata / knee O.A will be selected regardless of sex with will be selected randomly from O.P.D, I.P.D and Advanced Arthritis Research Clinic at state ayurvedic college and hospital, Lucknow and also the referred cases which fulfil the criteria who have not taken prior ayurvedic treatment.
A careful history, physical examination and necessary investigation will be performed as Performa prepared for the present trial.
Type of study - Two arm parallel randomized controlled study.
SAMPLE SIZE
Minimum 60 patients with approximately 10% of dropouts of janugata sandhivata from OPD, IPD and advance arthritis research Centre at SAC & H will be selected & divided into two groups with the help of computer-generated random table.
Group A – In this group patients will be treated with whole system of ayurveda and janu basti with active medicated oil ( Bala aswagandhadi oil)
Group B – In this group patients will be treated with whole system of ayurveda and janu basti with placebo control oil (Til tail)
INCLUSION CRITERIA
Patients who will be coming for the treatment of knee O.A in kayachikitsa OPD and A-ATARC OPD.
Patients who will be diagnosed as having knee O.A on the basis of their clinical and radiological features having grade 1, grade 2, grade 3.
Age: 31 to 60.
Sex: Both Male & Female.
Patients who have not taken any ayurvedic treatment earlier.
Patients who will give consent to participate in the study.
Family support to compliance treatment.
Controlled Thyroid, Hypertension, Diabetes.
EXCLUSION CRITERIA
Below 31 years and above 60 years of age.
Patients who have joint-related diseases other than knee osteoarthritis (OA).
Patients with osteoarthritis of knee joint of grade 4 and other systemic disorders Patients with traumatic knee O.A.
Unwilling patients will be excluded.
GROUPING OF PATIENTS
Group A – In this group patients will be treated with whole system of ayurveda and janu basti with active medicated oil ( Bala aswagandhadi oil)
Group B – In this group patients will be treated with whole system of ayurveda and janu basti with placebo controlled oil (Til tail)
Frequency and Duration
Frequency- 5 days in a week.
Duration -30 min.
Period of study: 90days (5 sitting in a week)
Follow up during trial period: At 30 days interval.
Follow up after the trial period: One month following the completion of the three month trial.
CRITERIA OF ASSESSMENT
OBJECTIVE PARAMETER:
Pain intensity in affected joint: determined visual analogue scale.
Change in walking time for a fixed distance (pre & post comparison)
Hantisandhi ( range of movement of knee joints pre and post comparison)
SUBJECTIVE PARAMETER:
All the signs and symptoms are graded on the basis of their intensity and severity given by patients on complained and confirmed by clinical examination before intervention.
The clinical improvement during and after the therapy will also be correlated with previous intensity of sign and symptoms.
COMMON CLINICAL SYMPTOMS
Vatapurnadritisparsa (crepitus)
Sandhi Shotha (joint swelling)
Prasaran akkunchanaana pravriti savedana (pain during flexion and extension of joint)
Tenderness of knee joints
Morning stiffness (<half an hour)
RADIOLOGICAL ASSESSMENT OF KNEE (OA)
Joint Space Narrowing
Osteophyte Formation
Subchondral Bone Sclerosis
ASSESSMENT OF THE RESULT
Assessment of the result will be done on the basis of symptomatic relief and the changes in the objective, subjective and radiological parameter before and after trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Patients who will be coming for the treatment of knee O.A in kayachikitsa OPD and A-ATARC OPD.
- Patients who will be diagnosed as having knee O.A on the basis of their clinical and radiological features having grade 1, grade 2, grade 3.
- • Age: 31 to 60.
- • Sex: Both Male & Female.
- Patients who have not taken any ayurvedic treatment earlier.
- Patients who will give consent to participate in the study.
- Family support to compliance treatment.
- Controlled Thyroid, Hypertension, Diabetes.
- Below 31 years and above 60 years of age.
- Patients who have joint-related diseases other than knee osteoarthritis (OA).
- Patients with osteoarthritis of knee joint of grade 4 and other systemic disorders Patients with traumatic knee O.A. Unwilling patients will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity in affected joint: determined visual analogue scale. Before trial,30th day,60th day,90th day, after trial. Change in walking time for a fixed distance (pre & post comparison) Before trial,30th day,60th day,90th day, after trial. Hantisandhi( range of movement of knee joints pre and post comparison) Before trial,30th day,60th day,90th day, after trial. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Before trial,30th day,60th day,90th day, after trial.
- Secondary Outcome Measures
Name Time Method RADIOLOGICAL ASSESSMENT OF KNEE (OA)using the Kellgren Lawrence grading system 1.Joint Space Narrowing
Trial Locations
- Locations (1)
State Ayurvedic college and Hospital
🇮🇳Lucknow, UTTAR PRADESH, India
State Ayurvedic college and Hospital🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Tahmina MuradPrincipal investigator7080211778shahtahmina181@gmail.com