| CTRI Number |
CTRI/2024/08/072537 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effects of Cannaquic Oil and Diclofenac Oil on Osteoarthritis: A clinical Study |
|
Scientific Title of Study
|
Evaluation of Safety and Efficacy of Cannaquic oil in comparison with Diclofenac oil for the management of Osteoarthritis – A Double-blind, Randomized controlled clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R C Satish Kumar |
| Designation |
Research professor and coordinator |
| Affiliation |
SRM Institute Science and Technology |
| Address |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri, Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845997 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R C Satish Kumar |
| Designation |
Research professor and coordinator |
| Affiliation |
SRM Institute Science and Technology |
| Address |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri, Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845997 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mothish waran B |
| Designation |
Clinical Research Associate |
| Affiliation |
SRM Institute of science and technology |
| Address |
Room No.19,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri, Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
mothishwaran26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hempcann solutions Pvt Ltd.
Plot No 266/3328, Nandan Kanan Road, Near Nandan Vihar Petrol Pump. Bhubaneswar, Odisha – 751024, India.
|
|
|
Primary Sponsor
|
| Name |
Hempcann solutions Pvt Ltd |
| Address |
Plot No 266/3328, Nandan Kanan Road, Near Nandan Vihar Petrol Pump. Bhubaneswar, Odisha – 751024, 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 R C satish kumar |
SRM Medical College Hospital and research centre |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Nagar Potheri, Chengalpattu.
Kancheepuram
TAMIL NADU |
9884845997
ayursatish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MCH & RC 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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Diclofenac oil | 3 ml twice daily for 30 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cannaquic oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: : Cannaquic oil is a formulation of 14 pain alleviating vata balancing herbs.
Local application is the effective and preferred route of drug administration for pain management. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with moderate to severe Arthritis with symptoms of pain and swelling, tenderness, morning stiffness, of one or more joint continuously for more than 3 weeks.
2. Subjects experiencing Musculo skeletal system with pain as major symptoms.
3. Subjects with confirmed diagnosis of osteoarthritis based on clinical evaluation and radiographic findings consistent with OA in one or more joints (e.g., knee, hip, hand) according to established criteria such as the American College of Rheumatology (ACR) criteria.
4. Subjects suffering from chronic pain with a baseline pain intensity of 6 or above on a 10-cm visual analog scale (VAS).
5. Patients receiving any other local medication for symptomatic management of pain can be included after a wash out period of 7 days.
6. Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with abnormal hematologic function (Hemoglobin 8gm/dl, WBC count 3000/mm3, platelet count 100,000/mm3).
2. Subjects with present known or signs of serious spinal pathology (i.e., cauda equine syndrome, trauma, fractures, or cancer); history of abdominal, lumbar, or lower limb surgery in the past year; rheumatologic disease in the acute inflammatory phase.
3. History of any deformities or any wound in the affected area.
4. Any concomitant serious disorders like hepatic dysfunction, chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer.
5. Evidence of psychiatric disorder (schizophrenia, suicidal tendency), Seizure, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
6. Gravid women and lactating mother.
7. Heavy smoker, Chronic alcoholic, or drug abuse subjects
8. Known cases of malignancy, HIV infection, AIDS, etc.
9. Subject who participated in any other clinical investigation using an experimental drug or has donated blood or had more than 300ml of blood drawn in the past 3 months.
10. Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the Efficacy of Cannaquic oil in the management of osteoarthritis.
2. Rapid recovery from symptoms.
3. The change in visual analog scale, and WOMAC score
|
1. To assess the Efficacy parameters after 30 days of treatment.
2. To evaluate the change in visual analog scale, and WOMAC score after 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out, the incidence of adverse events during the study period.
2. To evaluate treatment Adherence/Compliance
|
1. To evaluate the incidence of adverse events after 30 days.
2. To evaluate the treatment adherence after 30 days. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
11/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
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
|
Evaluation of Safety and Efficacy of Cannaquic Oil in Comparison with Diclofenac Oil for theManagement of Osteoarthritis – A Double-Blind Randomized Controlled Clinical Study Study Overview: 1. This study aims to explore a novel treatment approach for osteoarthritis (OA), a prevalent degenerative joint disease characterized by the deterioration of cartilage leading to pain, stiffness, and reduced joint function. Sponsored by Hempcann Solutions Pvt Ltd., this study investigates the efficacy and safety of cannaquic oil, an Ayurvedic formulation with pain-relieving properties derived from 14 vata-balancing herbs, in comparison to diclofenac oil, a commonly used NSAID. Design and Methodology: Study Design: Double-blind, randomized controlled trial Number of Participants: 80 Groups: One group receiving cannaquic oil and the other receiving diclofenac oil Duration: 30 days Application: Twice daily Primary Objectives: 1. 1. Assess the efficacy of cannaquic oil in managing osteoarthritis. 2. 2.Compare the safety and efficacy of cannaquic oil with diclofenac oil. Secondary Objectives: 1. 1. Evaluate the safety and tolerability of cannaquic oil through adverse event monitoring and laboratory parameters. 2. 2. Measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to the study’s conclusion. Inclusion Criteria: 1. 1.Males and females aged 18-65. 2. 2.Diagnosed with moderate to severe osteoarthritis, confirmed by clinical evaluation and radiographic findings. 3. 3.Experiencing significant pain. Exclusion Criteria: 1. 1.Severe comorbid conditions. 2. 2.Psychiatric disorders. 3. 3.Substance abuse issues. 4. 4.Recent participation in other clinical studies. Assessment and Evaluation: 1. Baseline and End-of-Study Assessments: Changes in pain levels, physical function, and adverse events. 2. Efficacy Evaluation: Clinical evaluations, visual analog scales, and WOMAC scores. 3. Safety Monitoring: Hematological and biochemical parameters. Objective: Provide a comprehensive evaluation of cannaquic oil as a potential alternative treatment for osteoarthritis, emphasizing a holistic Ayurvedic approach that could mitigate the side effects associated with conventional allopathic treatments like NSAIDs. The findings aim to contribute to the growing body of research on complementary and alternative medicine, offering new insights into managing osteoarthritis and improving the quality of life for affected individuals. |