| CTRI Number |
CTRI/2024/09/074336 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness and safety of 206B Topical Oil on Patients with Osteoarthritis. |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Topical Oil Formulation (206B) Containing Cannabis
Sativa and Boswellia Serrata in Patients with Osteoarthritis of Hip, Spine, and Knee: A
Prospective, Randomized, Double-blind, Placebo-Controlled Study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 206B-1075-2024-01, Version 1; dt. 19 th January 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Desai |
| Designation |
HOD of Orthopedics- Principal Investigator |
| Affiliation |
KEM Hospital |
| Address |
Department of Orthopaedics, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107463 |
| Fax |
|
| Email |
md1964@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashraf Shaikh |
| Designation |
M.S, Assistant Professor- Co-Principal Investigator |
| Affiliation |
KEM Hospital |
| Address |
Department of Orthopaedics, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9930214974 |
| Fax |
|
| Email |
ashrafshaikh123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Yash Kochar |
| Designation |
Director |
| Affiliation |
Pillcraft Private Limited |
| Address |
Pillcraft Private Limited,
501 Palm Court Link Road,
Malad West Mumbai 64, India.
Mumbai
MAHARASHTRA
400064
India |
| Phone |
9619503971 |
| Fax |
|
| Email |
yash@pillcraft.com |
|
|
Source of Monetary or Material Support
|
| Pillcraft Private Limited, 507, I Wing, Palm Court, Link Road, next to Infiniti Mall, Malad West, Mumbai-400064, India |
|
|
Primary Sponsor
|
| Name |
Pillcraft Private Limited, India. |
| Address |
507, I Wing, Palm Court, Link Road, next to Infiniti Mall, Malad West, Mumbai-400064 |
| 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 Mohan Desai |
KEM Hospital |
Room no. 604, 6th floor, Department of orthopaedics, KEM Hospital, New Building, KEM hospital,Mumbai, Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA |
02224107463
md1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: 206 B, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1.5(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - None | | 2 | Comparator Arm (Non Ayurveda) | | - | MCT Oil | Medium-Chain Triglyceride (MCT) Oil containing MCT (100%)
|
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (male and female) aged between 50 and 75 years.
2. Participants must have a confirmed diagnosis of osteoarthritis, as determined by clinical evaluation and relevant imaging studies.
3. Participants with osteoarthritis affecting major weight-bearing joints, such as the hip, spine, and knee.
4. Participants on stable doses of analgesic or anti-inflammatory medications for at least two weeks prior to the study.
5. No plan to commence new treatments over the study period.
6. Participants should be willing to adhere to the study protocol, including the use of topical Cannabis and Boswellia oil.
7. Participants must provide informed consent after being thoroughly informed about the study objectives, procedures. |
|
| ExclusionCriteria |
| Details |
1. Known allergies or hypersensitivity to cannabis, Boswellia, or any components of the topical formulations.
2. Participants with severe osteoarthritis or joint deformities that may require surgical intervention during the study period.
3. Participants with chronic pain conditions unrelated to osteoarthritis, such as rheumatoid arthritis, fibromyalgia, or neuropathic pain.
4. Recent changes in medication related to osteoarthritis treatment within the last two weeks.
5. Participants with active skin infections or dermatological conditions in the areas where the topical treatments will be applied.
6. History of substance abuse or dependence within the past year.
7. Patients who had participated in other clinical trials during the previous 3 months.
8. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
9. Uncontrolled medical conditions, such as uncontrolled hypertension or diabetes, that may interfere with study participation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in pain scores assessed on a 0-10 Visual Analog
Scale (VAS) from baseline. |
Baseline, Week 2, Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in scores for WOMAC-24 scale from baseline. |
Baseline, Week 2, Week 4 |
Mean change in scores for Short Form (SF-12) quality of life
questionnaire from baseline. |
Baseline, Week 2, Week 4 |
Number and proportion of patients who required rescue.
medications. |
Week 2, Week 4 |
| Number and proportion of rescue medications given to patients. |
Week 2, Week 4 |
Patient Global Assessment (PGA) for efficacy and tolerability at
end of treatment. |
Week 4 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2024 |
| Date of Study Completion (India) |
23/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
In this study, a total of 100 patients will be enrolled. At the initial visit, prospective patients would be screened for enrollment based on the requirements of the study, history, and clinical examination. Before starting any study-related procedures, patients would be explained about the study in detail and written informed consent would be obtained to participate in this study. A detailed medical history including the associated conditions will be recorded. A general and physical examination would be done to see any abnormal parameters. After satisfying the eligibility criteria, patients will be enrolled in the study. After enrollment in the study, Subjects will be asked to apply 206B topical oil containing Boswellia serrata gum-resin extract (50%), Cannabis sativa leaf extract (3%), and MCT Oil (47%) and identical placebo oil containing MCT (100%) thrice daily for 4 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. All subjects will be followed up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 2) ± 4 days, visit 3 (week 4) ± 4 days.The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study. |