| CTRI Number |
CTRI/2023/04/052115 [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, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the efficacy and safety of Ayurvedic treatment Kneesol oil to compare with Dr Ortho oil and Diclofenac gel in Osteoarthritis patients. |
|
Scientific Title of Study
|
An open labelled, randomized single centric comparative clinical Study to
evaluate the efficacy of the Ayurvedic Kneesol oil to claim substantiation in osteoarthritis
compared with Dr Ortho oil and Diclofenac gel (1% w/w) or Diclofenac spray (1mg).
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/HB/CT/23/12; Version 01 date: 16/03/2023 |
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 |
15093, 9th Floor, Tata New Haven,
Seshagirirao Palya Village,
Dasanpura Hobli,
Near The Golden Palms Hotel & Spa
Bengaluru North Taluka,
Karnataka
PIN: 562123
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,
Near Pal RTO, 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
|
|
|
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 Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Volini Pain relief Gel | Volini Gel contains active ingredients Menthol and Methyl Salicylate, as well as Diclofenac Diethylamine and Linseed oil. Dosage 2 times daily for 3 months, topical application | | 2 | Intervention Arm | Drug | Classical | | (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: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dr Orthofit Oil, Reference: Herbal, Route: Topical, Dosage Form: Dravaka, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.History of less than 30 min of morning sickness.
2. Clinical signs and symptoms corresponding to hip and/or knee
osteoarthritis for the previous three months.
3. Radiologically diagnosed osteoarthritis.
4. Subjects should have significant arthritic pain (Screening
WOMAC score between 10-40 or Visual Analogue Scale score
(VAS) between 4 to 9.
5. ESR < 40 mm/hr.
6. Willingness to sign the informed consent, follow the protocol and
participate in clinical trial voluntarily.
|
|
| ExclusionCriteria |
| Details |
1.Seriously overweight, defined as body mass index of >35
2. post-surgical pain patients
3. Alcohol or drug abuse during the last three years
4. Patients incapacitated or bound to wheel chair or bed and unable
to carry out self-care activities.
5. Patients administering any herbal or topical herbal pain relief
agents.
6. 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.
7. History of active peptic ulcer, severe renal, hepatic or
hemopoietic disease or severe cardiac insufficiency or undergoing
coronary artery bypass graft (CABG) surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. A decrease in WOMAC osteoarthritic index and
2. A decrease in the VAS scores.
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the change in the biochemical parameters (CRP, CTX-1, ESR, LFT).
2. To assess the change in the digitalized X ray for the gap between femur and tibia to be measured at three points for cartilage damage and recovery.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. Although osteoarthritis can damage any joint, the disorder most commonly affects joints in your hands, knees, hips and spine. Osteoarthritis symptoms can usually be managed, although the damage to joints can’t be reversed. Staying active, maintaining a healthy weight and receiving certain treatments might slow progression of the disease and help improve pain and joint function 1. Kneesol Oil is an advanced proprietary Ayurvedic medicine indicated for effective management of Pain & inflammation of knee and joints associated with Osteoarthritis. The Oil is rational combination of clinically reported potent anti-inflammatory & analgesic herbs formulated in a fixed oil by following traditional Ayurvedic processing methods. The ingredients of kneesol oil are Zinziger officicnale, Allium sativa, Trachyspermum ammi and Trigonella foenum-graceum. The phytochemical constituents like flavonoids, phenols, thymol and the active substances like selenium, allicin and organosulfur are responsible for suppressing or inhibiting the inflammatory pathways and thus decreasing the oxidative stress, thereby modulating the pain and inflammation caused by the osteoarthritic. |