| CTRI Number |
CTRI/2024/09/073526 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Lasuna Rasayana and Murivenna Bandage with Walking Aid in Chronic Knee Osteoarthritis |
|
Scientific Title of Study
|
Single arm clinical trial to assess the effect of Lasuna Rasayana and Murivenna Bandage with Walking Aid in Chronic Knee Osteoarthritis |
| 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 Meenakshi Chauhan |
| Designation |
Post graduation scholar |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department of Kayachikitsa Amrita School of Ayurveda Vallikavu Clappana P O Kollam Kerala pin code 690525
Kollam
KERALA
690525
India |
| Phone |
8826161727 |
| Fax |
|
| Email |
meenakshichauhan227@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreejith.k |
| Designation |
HOD Professor |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department of Kayachikitsa Amrita School of Ayurveda Vallikavu Clappana P O Kollam Kerala pin code 690525
Kollam
KERALA
690525
India |
| Phone |
9446127982 |
| Fax |
|
| Email |
sreejithk@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreejith.k |
| Designation |
HOD Professor |
| Affiliation |
Amrita School Of Ayurveda |
| Address |
Department of Kayachikitsa Amrita School of Ayurveda Vallikavu Clappana P O Kollam Kerala pin code 690525
Kollam
KERALA
690525
India |
| Phone |
9446127982 |
| Fax |
|
| Email |
sreejithk@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda vallikavu Kollam Kerala pin code 690525 |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi Chauhan |
| Address |
Amrita School of Ayurveda Vallikavu Clappana p.o kollam kerala pin code 690525 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi Chauhan |
Amrita School of Ayurveda |
Department of Kayachikitsa room number 1, Vallikavu Clappana p.o kollam Kerala pin code 690525
Kollam
KERALA |
8826161727
meenakshichauhan227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Shool of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: lasunaksheerapaka, Reference: sharangdhar madhyma khanda 2/3, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed knee osteoarthritis patients according to American College of Rheumatology clinical criteria.
Patients having Radiological changes of the Bilateral knee in the images by the X-ray Kellgren-Lawrence Index up to grade three.
laboratory finding- Erythrocyte Sedimentation Rate (ESR) less than forty millimeter per hour
40years - 70 years of age, irrespective of gender, religion and occupation
Patients willing to sign the consent form
|
|
| ExclusionCriteria |
| Details |
Patients having auto-immune related joint disorders like Multiple sclerosis RA Polymyalgia rheumatic
Severe joint deformities secondary to any other complaints like rheumatoid arthritis gout
People with pre diagnosed systemic illness like Hypothyroidism Metabolic syndrome Ulcerative colitis and other deficiency diseases
Septic arthritis infectious arthritis
Lactose intolerance
Sulphur allergy
History of any trauma or fracture to the joints in the previous 6 months
Obesity
Pregnant or Lactating Mothers
Diagnosed cases of carcinoma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the changes in the scores of VAS scale and WOMAC scale pre and post intervention
|
30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF 36 QOL questionnaire |
SF 36 QOL questionnaire assessment at 0th and 31st day
|
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
Final Enrollment numbers achieved (Total)= "29"
Final Enrollment numbers achieved (India)="29" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Knee Osteoarthritis (OA) is a non-inflammatory degenerative joint disease characterized by focal loss of cartilage with accompanying periarticular bone response in the form of subchondral bone sclerosis and attempted new bone formation called osteophytes. OA involves all components of the joint, including bone, cartilage, meniscus and synovium. OA clinically presents as joint pain and crepitus affecting gait and quality of life in the elderly. Ayurveda describes this condition as Janu Sandhigata Vata in terms of signs and symptoms, Lasuna rasayana is mentioned in ashtang hridya uttarsthana in rasayana chapter and explained as ’’stabdha bhagna kutila vyathita asthnaam’’.Considering of the lasuna rasayana’s dosage and palatable issue, lasuna is utilized as lasunaksheerapaka in this study and it is necessary to have a koshtha suddhi before administering Rasayana. for this reason, Gandharvahasthadi Eranda tailam is useful. For the external treatment, Murivenna has given excellent results in repairing the wear and tear of knee joints in chronic OA as supported by long standing clinical practice. Walking aid explained in Ayurveda as Danda dharana which is avashtambnabalpradam as mentioned by acharya charak in matrashitiya adhaya. Hence this study aims to explore the combined effect of lashuna rasayana, snehana, bandhana and danda dharana in the management of chronic knee OA.
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