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CTRI Number  CTRI/2023/04/052114 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 06/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized Factorial Trial 
Public Title of Study   A clinical study to assess the efficacy and safety of Ayurvedic treatment Kneesol oil to compare with Dr Ortho oil and Diclofenac gel in Rheumatoid arthritis patients. 
Scientific Title of Study   A clinical trial to assess the efficacy of the Ayurvedic Kneesol oil to claim substantiation in Rheumatoid arthritis on comparison with Dabur Rheumatil oil and Diclofenac gel (1% w/w) or spray (1 mg): An open labelled randomized single centric comparative three arm study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SP/HB/CT/23/11, Version 01 dated 15/03/2023   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh G 
Designation  Associate professor, Dept. of Othopedics 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  1st Floor, Dept. of Orthopaedics, No-15, Chikkasandra, Hesaraghatta Main Road.

Bangalore
KARNATAKA
560090
India 
Phone  9964428994  
Fax    
Email  drmaheshg85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Baburao Vikram 
Designation  Director 
Affiliation  Pharexcel Consulting Private Limited 
Address  Ground Floor, Plot 11, 10th Cross, AYR Layout, Shettyhalli, Jalahalli West

Bangalore
KARNATAKA
562123
India 
Phone  9878551428  
Fax    
Email  info@pharexcelconsulting.com  
 
Details of Contact Person
Public Query  
Name  Gagan Goswami 
Designation  Director 
Affiliation  Cyizen Pharma Solutions Private Limited 
Address  238, The Galleria hub, Opp. New RTO, Pal, Adajan, Surat, Gujarat- 395009

Surat
GUJARAT
395009
India 
Phone  9662545775  
Fax    
Email  gagan@cyizen.com  
 
Source of Monetary or Material Support  
Madhusudan Healthcare Plot No. 180 to 189, Block No. 281 to 283, Laxminarayan Ind. Estate, Village-Baleshwar, Taluka- Palsana, Dist. Surat-394317, Gujarat, India 
 
Primary Sponsor  
Name  Madhusudan Healthcare  
Address  Plot No. 180 to 189, Block No. 281 to 283, Laxminarayan Ind. Estate, Village-Baleshwar, Taluka- Palsana, Dist. Surat-394317, Gujarat, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Mahesh G  Sapthagiri Institute of Medical Sciences & Research Centre (SIMSRC)  No-15, Chikkasandra, Hesaraghatta Main Road, Bengaluru-560090
Bangalore
KARNATAKA 		 9964428994

drmaheshg85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri Institute of Medical Sciences and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Dabur Rheumatic Oil, Reference: Herbal, Route: Topical, Dosage Form: Dravaka, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Kneesol Oil, Reference: Herbal, Route: Topical, Dosage Form: Dravaka, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
3Comparator Arm (Non Ayurveda)-Volini Pain Relief GelVolini Gel contains active ingredients Menthol and Methyl Salicylate, as well as Diclofenac Diethylamine and Linseed oil. Treatment 3 months, Two times daily, Topical treatment
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Aged between 18 and 75 years old of either sex.
2. If rheumatoid arthritis is moderately or severely active, the disease activity during the screening period and the baseline period must meet the following criteria:
Swollen joints count (SJC) ≥ 6 (based on 66 joint count) and tender joints count (Tender joints count: TJC) ≥ 6 (based on 68 joint count) (if the same joint has both swelling and Tenderness, this joint is included in the counts of swollen joints and tender joints).
3. Morning stiffness in and around the joints for at least 6 weeks which is lasting at least 1 hr before the maximal improvement.
4. Take medically approved non-drug contraceptive measures (such as drug-free intrauterine devices, condoms, female sterilization, and male sterilization) during the entire trial period and at least 3 months after the end of the medication, and no Pregnancy planner.
5. Those who understand, voluntarily sign the informed consent form, and comply with the requirements of the research plan.
 
 
ExclusionCriteria 
Details  1. Those who have received any medical supportive treatments (such as whitening drugs, drugs for anaemia (except folic acid), liver-protecting and enzyme-lowering drugs, blood transfusions, etc.) within 2 weeks before screening.
2. Patients with acute myocardial infarction, unstable angina pectoris, stroke, and cardiac insufficiency within 6 months before screening.
3. The kidney, lung, digestive tract, nervous system and other serious diseased individuals (such as: poorly controlled severe diabetes, hypertension, interstitial pneumonia, obstructive Lung disease, bronchospasm, etc.), the investigator judged that it is not suitable to join the research.
4. Those who have a history of smoking, alcoholism, or drug abuse within 12 months before screening.
5. People with other primary or secondary immunodeficiencies in the past or at the time of screening, including patients with a history of HIV infection and positive HIV test results.
6. Patients administering any herbal or topical herbal pain relief agents.
7. The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnotic, excessive alcohol, NSAIDs.
8. Those who have participated in other clinical studies within 3 months before screening.
9. Women who are preparing for pregnancy, pregnancy, lactation, or who become pregnant during the planned trial period

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the percentage of patients achieving a 20% of ACR response rate
SECONDARY OUTCOME
 		 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
. To estimate the change in DAS 28 score, VAS scoresand HAQ disability index (HAQDI) from baseline.
2. Change in the acute phase reactants ESR (mm/hr) and CRP (mg/L) which are unspecific and sensitive markers of the inflammatory process.
3. To evaluate the biochemical parameters (Anti-CCP, CRP, ESR, RA-Factor), digitalized X ray (for margin between knee joints ie gap between femur and tibia to be measured at three points for cartilage damage and recovery) on the basis of the physical examination done by an orthopedist before the treatment and after the treatment and after the completion of the study to compare for any changes (if any).
 		 12 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 4 
Date of First Enrollment (India)   29/04/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The results of the study will be the property of sponsor and so no one can publish study data without permission of sponsor 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Rheumatoid arthritis is an autoimmune disease. A chronic inflammatory disorder affecting many joints in which the body’s immune system attacks its own tissue, including those in the hands and feet. In severe cases, it attacks internal organs.

Rheumatoid arthritis affects joint linings, causing painful swelling. Over long periods of time, the inflammation associated with rheumatoid arthritis can cause bone erosion and joint deformity.

While there’s no cure for rheumatoid arthritis, physiotherapy and medication can help slow the disease’s progression. Most cases can be managed with a class of medications called anti-rheumatic drugs (DMARDS).

An advanced proprietary Ayurvedic medicine, Kneesol oil was indicated for effective management of pain and inflammation in knee and joints associated with rheumatoid arthritis. Clinically reported potent anti-inflammatory & analgesic herbs were rationally combined and formulated to a fixed oil by following traditional Ayurvedic processing methods. The key ingredients Zinziger officicnale, Allium sativa, Trachyspermum ammi and Trigonella foenum-graceum were used in the preparation of kneesol oil. The active phytochemical constituents like flavonoids, phenols, thymol and the dynamic materials like selenium, allicin and organosulfur are responsible for either suppressing or inhibiting the inflammatory pathways and thus diminishing the oxidative stress, thereby restraining the pain and inflammation caused by the rheumatoid arthritis 
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