| CTRI Number |
CTRI/2025/01/079216 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Relief for Musculoskeletal Pain: Comparing the Benefits of Kwik Pain Oil and Tila Taila |
|
Scientific Title of Study
|
Comparative Clinical Study to Assess the Efficacy and Tolerability of Kwik Pain Oil and Tila Oil in Musculoskeletal Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University (De Novo)) |
| Address |
Department of Dravyaguna Vigyana, National Institute of Ayurveda (De Novo), Near Jorawar Singh Gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University (De Novo) |
| Address |
Department of Dravyaguna Vigyana, National Institute of Ayurveda (De Novo), Near Jorawar Singh Gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani2@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Krishnan |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University (De Novo) |
| Address |
Department of Dravyaguna Vigyana, National Institute of Ayurveda (De Novo), Near Jorawar Singh Gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
9965047479 |
| Fax |
|
| Email |
vijaykrishnanmb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Monetary & material support by Ozone Pharmaceutical Ltd. Ozone House, Block A-3, 1 LSC, Janak Puri, New Delhi, Delhi, India, 110058 and Infrastructure support by National Institute of Ayurveda, Near Jorawar Singh Gate, Jaipur, Rajasthan, India, 302002. |
|
|
Primary Sponsor
|
| Name |
Ozone Pharmaceutical Limited |
| Address |
Ozone House, Block A-3, 1 LSC, Janak Puri, New Delhi, Delhi 1100058 |
| 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 Sumit Nathani |
National Institute of Ayurveda |
OPD Room No: 19, Dravyaguna Vigyana
Jaipur
RAJASTHAN |
7665809886
sumitnathani2@rediff.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Kwik Pain Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 9(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tila Taila, Reference: Charaka Samhita Chikitsa sthana 28/181-182, Route: Topical, Dosage Form: Taila, Dose: 9(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign the consent form of the clinical trial. Outdoor patients, having chronic pain of musculoskeletal origin (e.g., low backache, knee, shoulder, elbow, wrist, ankle, and neck pain for more than 4 weeks) |
|
| ExclusionCriteria |
| Details |
History of any trauma/fractured joint/surgical/diagnostic intervention with reference to the affected joint(s), Gross disability in performing daily normal routine, i.e., bed-ridden patients or confined to a wheelchair Patients with co-morbidities such as gouty arthritis, rheumatoid arthritis, and psoriatic arthritis, Patients having any deformity of knee hip or back altering their gait and posture Concomitant use of pain-relieving medications, Patients on prolonged (more than 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc., or any other drugs that may have an influence on the outcome of the study, Allergy to ‘Kwik Pain Oil’ or Tila Taila. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Visual Analogue Scale (VAS) for Pain, Pain relief period, Duration of pain free period |
At baseline, 1st week and 2nd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction & Adverse effects. |
At 1st & 2nd week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Musculoskeletal pain, encompassing discomfort in the muscles, bones, ligaments, tendons, and nerves, is a prevalent health issue that affects individuals of all ages. It can be acute, arising from injuries or overuse, or chronic, resulting from underlying conditions such as arthritis or fibromyalgia. The pain may manifest as stiffness, inflammation, or tenderness, often limiting mobility and affecting overall quality of life. In Ayurveda, the primary cause of musculoskeletal disorders is the aggravation of Vata Dosha. Contributing factors, known as Nidana Sevana, include the consumption of Vata-aggravating foods, excessive physical exertion, intake of unwholesome food, and a sedentary lifestyle. When Vata Dosha becomes aggravated, it obstructs the body’s empty channels, leading to the development of musculoskeletal disorders, which can affect either a specific part of the body or the entire system. Kwik Pain Oil will be prepared and provided by Ozone Pharmaceutical Ltd. Test Drug Composition: Each 100 ml contains: Ingredients Gandhpura Taila (Gaultheria fragrantissima) Lf. Oil 15 g, Mahanarayan Taila 5 g, Vishagarbha Taila 5 g, Brihatmash Taila 5 g, Pudina Ka Phool (Mentha spicata) Crystal 5 g, Atasi Taila (Linum usitatissimum) Seed Oil 3 g, Tailaparnah Taila (Eucalyptus globulus) Lf. Oil 2 g, Kapoor (Cinnamomum camphora) Plant Ext. Powder 1 g, Capsaicin Resin (Capsicum minimum) Fruit 0.002 g, Ajwain Taila (Trachyspermum ammi) Seed Oil 0.75 g, Base q.s. Objectives - Primary Objective – 1. To assess the efficacy of local application of ‘Kwik Pain Oil’ for its effect on musculoskeletal pain. 2. To compare the efficacy of ‘Kwik Pain Oil’ and tila taila in the management of musculoskeletal pain. Secondary Objective – 3. To assess the safety and tolerability of local application of ‘Kwik Pain Oil’. |