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CTRI Number  CTRI/2024/07/070308 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assessing the outcome of Low Level Laser Therapy on participants of Janugata Sandhivata (Knee Osteoarthritis) already treated with ayurvedic medicine 
Scientific Title of Study   Evaluation of the effects of add on low level laser therapy on functional outcomes in janugata sandhivata (knee osteoarthritis) treated with whole system ayurveda a single blinded randomized 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  Dr Nishu Saini 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow

Lucknow
UTTAR PRADESH
226004
India 
Phone  07895998238  
Fax    
Email  saininishu05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Rastogi 
Designation  Reader 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow

Lucknow
UTTAR PRADESH
226004
India 
Phone  09415022955  
Fax    
Email  rastogisanjeev@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeev Rastogi 
Designation  Reader 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow

Lucknow
UTTAR PRADESH
226004
India 
Phone  09415022955  
Fax    
Email  rastogisanjeev@rediffmail.com  
 
Source of Monetary or Material Support  
Post Graduate Department of kayachikitsha,State Ayurvedic College And Hospital Tulsidas marg, Tudiyaganj, Lucknow UTTAR PRADESH 226004 INDIA  
 
Primary Sponsor  
Name  State Ayurvedic College And Hospital Lucknow 
Address  State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow UTTAR PRADESH 226004 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 Nishu saini  State Ayurvedic College And Hospital Lucknow  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Lucknow 226004 Tulsidas Marg, Tudiyaganj, Lucknow UTTAR PRADESH 226004 India
Lucknow
UTTAR PRADESH 		 07895998238

saininishu05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Institutional Ethics Committee state ayurvedic college and hospital lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-निरग्निस्वेदः / low level laser therapy (Procedure Reference: charak sutrasthan Sweda Adhyaya , Procedure details: We will be using low level laser apparatus for conducting niragni svedanam in patients of janugata sandhivata(~ knee osteoarthritis) which involves the use of low intensity lasers or light-emitting diodes (LEDs) to irradiate the affected area with medicine (Abha guggul & Lakshadi guggul) to patients in both intervention & comparator arm. Frequency and time duration: Frequency: Twice a week Time duration: For 10 to 15 min. )
(1) Medicine Name: Abha guggul, Reference: Bhaishjya Ratnavali (bhagna) 49/15, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 2 Months
(2) Medicine Name: Lakshadi guggul, Reference: bhavpraksasha madhyam khanda 34, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 2 Months
2Comparator ArmProcedure-निरग्निस्वेदः / placebo or sham control low level laser therapy (Procedure Reference: charak sutrasthan Sweda Adhyaya 14, Procedure details: In comparator arm we will be using same low level laser apparatus for Niragani Svedanam , but that particular apparatus does not involve the use of low-intensity lasers beam or light-emitting diodes (LEDs) to irradiate the affected area with medicine (Abha guggul & Lakshadi guggul) to patients. )
(1) Medicine Name: Abha guggul, Reference: Bhaishjya Ratnavali (bhagna) 49/15, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 2 Months
(2) Medicine Name: Lakshadi guggul, Reference: bhavpraksasha madhyam khanda 34, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 2 Months
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients who will be coming for the treatment of knee O.A in kayachikitsa OPD and A-ATARC OPD.
2.Patients who will be diagnosed as having knee O.A on the basis of their clinical and radiological features.
3.Socio economic status: All
4.Patients who will give consent to participate in the study.
5.Patients who will be agree to stop all previous medications of knee OA.
 
 
ExclusionCriteria 
Details  1.Patients below 31 years and above 70 years of age.
2.Patients having severe destructive radiological changes.
3.Patients suffering from systemic disease like Carcinoma, uncontrolled diabetes, Tuberculosis etc.
4.Patients who have joint-related diseases other than knee osteoarthritis (OA).
5.Patients with traumatic knee O.A, gross deformity, meniscal tear etc.
6.Unwilling patients will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Subjective assessment:
Sandhishoola( knee joint pain)
Atopa (crepitus on movement)
Restriction of movement
Tenderness
Stambha(stiffness)
Objective assessment:
Pain on VAS
WOMAC osteoarthritis index
Range of movement measured with goniometer
Shopha(joint swelling by measuring girth)
Radiological findings X ray imaging of knee joint in lateral and anterio-posterior view 		 before trial,15days , 30days,45days,60days, after one month of trial  
 
Secondary Outcome  
Outcome  TimePoints 
Health assessment questionnaire (HAQ)  before trial,15days , 30days,45days,60days, after one month of trial  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   31/07/2024 
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="1"
Months="5"
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   EVALUATION OF THE EFFECTS OF ADD ON LOW LEVEL LASER THERAPY ON FUNCTIONAL OUTCOMES IN JANUGATA SANDHIVATA (~KNEE OSTEOARTHRITIS) TREATED WITH WHOLE SYSTEM AYURVEDA: A SINGLE BLINDED RANDOMIZED CONTROL TRIAL

AIMS AND OBJECTIVES 

 AIM: To find out the additional benefits of Low level laser therapy LLLT on the patients of knee O.A

 to receiving the whole system ayurveda intervention.

Primary objective:

To asses if the addition of LLLT is providing additional functional benefits to knee O.A patients in terms of functional outcome. 

  Secondary objective:

  1. To asses if the benefit obtained by low level laser therapy LLLT in such patients are stable (for 2 months) after stopping of the LLLT.   
  2. To asses if the addition of laser therapy is safe in its application.
  3. Min. number of sittings required to obtain the visible therapeutic responses as well as the maximum therapeutic response.
  4. To study the drug and procedure related adverse drug reaction (ADR) during the trial period
  5. To asses if there is any need of reduction in analgesics.

PLAN OF STUDY

 

         Selection of cases

 

1.    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.

 

2.A careful history, physical examination and necessary investigation will be performed as Performa prepared for the present trial.

 

 

          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.

Age: 31 to 70 years.

Sex: Both Male & Female.

Socio economic status: All

Patients who will give consent to participate in the study.

 Patients who will be agree to stop all previous medications of knee OA.

 

 

           EXCLUSION CRITERIA

     

Patients below 31 years and above 70 years of age.

Patients having severe destructive radiological changes.

Patients suffering from systemic disease like Carcinoma, uncontrolled diabetes, Tuberculosis etc.

Patients who have joint-related diseases other than knee osteoarthritis (OA).

 Patients with traumatic knee O.A, gross deformity, meniscal tear etc.

Unwilling patients will be excluded.


Type of study - Two arm parallel randomized controlled study.

Period of study: 120 days (60 days interventionally+60 days after trial completion).

Follow up during trial period:  At 15 days interval.

 Follow up after the trial period: One month following the completion of the two-month trial.

 

SAMPLE SIZE

 

Minimum 50 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.

 

4.     Group A â€“ In this group patients will be treated with whole system of ayurveda and Low-Level Laser Therapy.

 

5.    Group B – In this group patients will be treated with whole system of ayurveda and sham control.

 

 


 

 OUTCOME ASSESSEMENT




ASSESSMENT OF RESULTS:

For the gross assessment of result obtained, the response of the treatment will be determined in terms of degree of remission of sign and symptoms as:

1. Relieved: The patients having improvement > 75% symptomatically and in radiological and laboratory findings (if any).

2. Improved: The patients having improvement < 75% and > 40% symptomatically, Radiological and laboratory findings (if any)

3.Not Improved : Patients having improvement < 40% symptomatically and in Radiological and laboratory findings (if any).

4.Worsened Response :Patients having deterioration in their symptoms, and in Radiological and laboratory finding (if any).

 
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