A Clinical Study on Topical Pain formulation in arthritis
Scientific Title of Study
Efficacy of a Topical Pain formulation in participants suffering from Osteoarthritis of Knee(s) - A randomized, double blind, placebo controlled, multi-centric, comparative, prospective study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
OA/TPF/Hale/2024/01, Version 2.0 Dated 6th Sept 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kuldip Raj Kohli
Designation
Chief Investigator
Affiliation
Kohli’s Ayurveda and Panchakarma Centre (KAPC)
Address
Kohli’s Ayurveda and Panchakarma Centre (KAPC)
11, Ground Floor, OPD Department, Padmavati Darshan Building, Near Deepak Cinema, Delisle Rd, NM Joshi Marg, Lower Parel, Mumbai, Maharashtra
Mumbai MAHARASHTRA 400013 India
Phone
8108029777
Fax
Email
kohliayurveda1@gmail.com
Details of Contact Person Scientific Query
Name
Dr Atul Sharma
Designation
Senior Scientist
Affiliation
Haleon India
Address
Haleon India,
10th Floor, DLF One Horizon Center Golf Course Road,
DLF Phase 5, Gurgaon, India,
Gurgaon HARYANA 122002 India
Phone
9820801694
Fax
Email
atul.x.sharma@haleon.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt. Ltd
Address
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Haleon India,
10th Floor, DLF One Horizon Center Golf Course Road,
DLF Phase 5, Gurgaon, India, 122002
Primary Sponsor
Name
Haleon India
Address
10th Floor, DLF One Horizon Center Golf Course Road,
DLF Phase 5, Gurgaon, India, 122002
Type of Sponsor
Other [Global Consumer Healthcare ]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 7
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Pankaj Dixit
Ayurved Seva Sangh, Ayurved Mahavidyalaya,
Department of Shalya Tantra
OP no 6, Ground Floor, Ganeshwadi, Nashik 422003
Nashik MAHARASHTRA
9011045371
drpankajpdixit@gmail.com
Dr Nikhil H Joglekar
D.Y. Patil School of Ayurveda, D. Y. Patil University
Department of Kayachikitsa
OPD no 1, First floor, Sector 7, Nerul, Navi Mumbai, 400706 Mumbai (Suburban) MAHARASHTRA
8767772865
drnikhiljoglekar@gmail.com
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital
Department of Kayachikitsa, OPD No 5, Ground Floor, Boradi, Tal. Shirpur, Dist. Dhule, 425428
Dhule MAHARASHTRA
09850378206
drnbmundhe@gmail.com
Dr Kamalakar Gajare
MAM’S Sumati Bhai Shah Ayurved Mahavidyalaya, and Sane Guruji Arogya Kendra
Department of Shalya Tantra, OPD no.3, Ground floor, Malwadi, Hadapsar, Pune – 411028 Pune MAHARASHTRA
9822071732
drgajarekv@gmail.com
Dr Nilesh Londhe
Nirvikar Ayurveda Hospital
Department of General OPD,
OPD No. 1, First Floor, B Wing, JayGanesh Samrajya, Pune Nashik Hwy, Sector No. 3, Bhosari, Pimpri Chinchwad,
Pune 411039 Pune MAHARASHTRA
9881572395
drnileshlondhe@gmail.com
Dr Shailesh Deshpande
Parul Institute of Ayurveda and Hospital, Parul university
Department of Kayachikitsa,
OPD No. 108, Ground Floor Post. Ishwarpura - Limda, Taluka. Waghodia, Dist. Vadodara, Gujrat 391760
Vadodara GUJARAT
Institutional Ethics Committee, Ayurved seva Sangh’s Ayurved Mahavidyalaya, Nashik
Approved
Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi
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
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Topical Pain Formulation , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: tds, Bhaishajya Kal: Samudga, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Apply a thin layer of Topical Pain formulation onto the skin of the affected area of knee joint, 3 times daily for 28 days.
2
Comparator Arm (Non Ayurveda)
-
Placebo Formulation
Apply a thin layer of Placebo formulation onto the skin of the affected area of knee joint, 3 times daily for 28 days.
Inclusion Criteria
Age From
30.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Clinically diagnosed cases of knee pain due to Osteoarthritis
2. Knee joint(s) pain between 30 to 70 on Visual Analogue Scale (VAS) (both
inclusive) (mild to moderate pain)
ExclusionCriteria
Details
1. Known chronic severe (more than four years) cases of OA and having
developed any kind of joint deformity.
2. Known cases of rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis
other than OA, Pagets disease of bone, chronic pain syndrome, fibromyalgia,
or another major joint disease
3. Participants with history of surgery, including arthroscopy, or major trauma to
the study joint in the previous six months before the screening visit
4. Participants requiring knee arthroplasty within 6 months of screening or
anticipating any need for a surgical procedure on the index joint during the
study
5. Participants using systemic corticosteroids within 1 month of screening,
6. Intra articular visco supplementation within the past 3 months
7. Participants with any other investigational drug within 1 month prior to
randomization;
8. Participants with uncontrolled diabetes mellitus and hypertension
9. Participants with known tuberculosis, HIV, ischemic heart disease, cancer,
kidney failure
10. Pregnant and lactating women
11. Known hypersensitivity to any of the ingredients of Study drugs or to
NSAIDs
12. Other conditions, which in the opinion of the investigators, makes the patient
unsuitable for enrolment or could interfere with his her participation in, and
completion of the protocol
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Change in knee joint pain on Visual Analogue Scale
2. Change in joint swelling (inflammation) using knee joint girth
measurements
1. Change in pain, stiffness and physical function using graded scale
2. Change in knee joint tenderness and warmness on graded scale
3. Time of onset of action (as pain reliever) after application in min/hrs.
4. Duration of action (as pain reliever) after application in min/hours
5. Global Assessment for overall change in OA by subject and investigator
Total Sample Size="300" Sample Size from India="300" 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/ Phase 3
Date of First Enrollment (India)
11/11/2024
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="0" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
It is a randomized, double blind, placebo controlled, multi-centric,
comparative, prospective clinical study to evaluate efficacy of a Topical Pain
formulation in participants suffering from Osteoarthritis of Knee(s). The study
will be carried out at 6 to 7 sites in India. As per computer generated randomization list, participants will be
randomized either to Topical Pain formulation group or placebo formulation
group. Participants will be asked to apply a thin layer of given mediation onto
the skin of the affected area of knee joint, 3 times daily for 28 days. The
primary objectives of the study will be to assess change in knee joint pain on
Visual Analogue Scale and change in joint swelling (inflammation) using knee
joint girth measurements. The secondary objectives of the study will be to
assess change in pain, stiffness and physical function using graded scale,
change in knee joint tenderness and warmness on graded scale, time of onset of
action (as pain reliever) after application in min/hrs, duration of action (as
pain reliever) after application in min/hours, global Assessment for overall
change in OA by subject and investigator on baseline visit, visit 1 (Day 14)
and visit 2 (Day 28)