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CTRI Number  CTRI/2025/04/085052 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 17/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Check The Efficacy of Janu Basti in cases of Knee Joint Pain. 
Scientific Title of Study   A study To Evaluate The Efficacy of Janu Basti As An Add On Therapy To Whole System Ayurveda In Cases Of Knee Osteoarthritis A Randomized Placebo Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tahmina Murad  
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital, Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow,226004 Uttar Pradesh India

Lucknow
UTTAR PRADESH
226004
India 
Phone  7080211778  
Fax    
Email  shahtahmina181@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gurmeet Ram 
Designation  Reader 
Affiliation  State Ayurvedic College and Hospital, Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow,226004 Uttar Pradesh India

Lucknow
UTTAR PRADESH
226004
India 
Phone  9412360556  
Fax    
Email  gurmeet.dr70@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tahmina Murad  
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital, Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow,226004 Uttar Pradesh India

Lucknow
UTTAR PRADESH
226004
India 
Phone  7080211778  
Fax    
Email  shahtahmina181@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow,226004 Uttar Pradesh India 
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital, Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow,226004 Uttar Pradesh India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tahmina Murad  State Ayurvedic college and Hospital   Post Graduate Department of Kayachikitsa, Gathiya Center Room no. 10, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow,226004 Uttar Pradesh India
Lucknow
UTTAR PRADESH 		 7080211778

shahtahmina181@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAC Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Sahastrayog, Procedure details: Group B POORVA KARMA (PREOPERATIVE PROCEDURE): Patient is informed regarding the whole procedure. Consent for the procedure will be taken & evaluation of patient’s safety for before procedure as per pre procedure checklist will be done. Gathered necessary materials: Til tail (group-B), Maşapiştī, steel rim, gas cylinder, stove, sponge, spoon & a bowl. Cleaned the surface area of the knee joint (Jānusandhi) with lukewarm water. Positioned the patient comfortably on the Abhyanga table with the affected leg straight with properly exposed affected area. 2. PRADHAN KARMA(OPERATIVE): Attached the steel rim with Maşapiştī to the anterior part of the knee joint (Janu sandhi). Poured medicated lukewarm oil into the rim using a sponge or spoon filling it up to a level of 2 Angula (6cm). After confirming a tolerable temperature, the oil is poured within the constructed circular boundary with caution. Temperature of the oil was consistently monitored & maintained throughout the procedure. To maintain the temperature of oil at 45̊C, oil from the reservoir was periodically removed using cotton or spoon & replaced with warm oil. Allowed the oil to remain on the knee joint for 30 minutes. 3. PASCHAT KARMA (Post-Operative): Removed the oil & steel rim/Maşapiştī (black gram flour) after completing the treatment. After removing the oil & basti yantra massage was done in circular motion for 5 minutes covering the whole aspect of knee joint. Cleaned the knee joint with lukewarm water. Advised the patient to avoid direct exposure of air. Along with janu basti, internal & external medicine from the whole system ayurveda will be prescribed to the patients. Total duration:90 days Follow up including trial:120 days)
2Intervention ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Sahastrayog, Procedure details: Group A POORVA KARMA (PREOPERATIVE PROCEDURE): Patient is informed regarding the whole procedure. Consent for the procedure will be taken & evaluation of patient’s safety for before procedure as per pre procedure checklist will be done. Gathered necessary materials: Bala Aashwagandha tail (group-A), Maşapiştī, steel rim, gas cylinder, stove, sponge, spoon & a bowl. Cleaned the surface area of the knee joint (Jānusandhi) with lukewarm water. Positioned the patient comfortably on the Abhyanga table with the affected leg straight with properly exposed affected area. 2. PRADHAN KARMA(OPERATIVE): Attached the steel rim with Maşapiştī to the anterior part of the knee joint (Janu sandhi). Poured medicated lukewarm oil into the rim using a sponge or spoon filling it up to a level of 2 Angula (6cm). After confirming a tolerable temperature, the oil is poured within the constructed circular boundary with caution. Temperature of the oil was consistently monitored & maintained throughout the procedure. To maintain the temperature of oil at 45̊C, oil from the reservoir was periodically removed using cotton or spoon & replaced with warm oil. Allowed the oil to remain on the knee joint for 30 minutes. 3. PASCHAT KARMA (Post-Operative): Removed the oil & steel rim/Maşapiştī (black gram flour) after completing the treatment. After removing the oil & basti yantra massage was done in circular motion for 5 minutes covering the whole aspect of knee joint. Cleaned the knee joint with lukewarm water. Advised the patient to avoid direct exposure of air. Along with janu basti, internal & external medicine from the whole system ayurveda will be prescribed to the patients. Total duration:90 days Duration including follow up:120 days)
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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)
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 		 Before trial,30th day,60th day,90th day, after trial. 
 
Secondary Outcome  
Outcome  TimePoints 
RADIOLOGICAL ASSESSMENT OF KNEE (OA)using the Kellgren Lawrence grading system
1.Joint Space Narrowing
2.Osteophyte Formation
3.Subchondral Bone Sclerosis 		 Before trial,30th day,60th day,90th day, after trial. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.


 
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