| CTRI Number |
CTRI/2018/10/016235 [Registered on: 31/10/2018] Trial Registered Prospectively |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Herbal Oil in Osteoarthritis of Knee |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled comparative study to assess the efficacy and safety of Gogo Pain Relief & MSM (M) oil in treatment of osteoarthritis (OA) of the knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GOS/CMS/13/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitendra Singh Kushwaha |
| Designation |
Sr. Consultant Physician |
| Affiliation |
Prakhar Hospital Pvt. Ltd. |
| Address |
8/150, Arya Nagar Road, Near Indian Overseas Bank
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
drortho2711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Singh Kushwaha |
| Designation |
Sr. Consultant Physician |
| Affiliation |
Prakhar Hospital Pvt. Ltd. |
| Address |
8/150, Arya Nagar Road, Near Indian Overseas Bank
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
drortho2711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitendra Singh Kushwaha |
| Designation |
Sr. Consultant Physician |
| Affiliation |
Prakhar Hospital Pvt. Ltd. |
| Address |
8/150, Arya Nagar Road, Near Indian Overseas Bank
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7906261455 |
| Fax |
|
| Email |
drortho2711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gods Own Store LLP, Amritpuri opp Iskcon Temple East of Kailash New Delhi India |
|
|
Primary Sponsor
|
| Name |
Gods Own Store LLP |
| Address |
Amritpuri opp Iskcon Temple East of Kailash New Delhi India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jitendra Singh Kushwaha |
Prakhar Hospital Pvt Ltd |
Room No. 405, Clinical Research Room, 4th Floor, 8/150, Arya Nagar Road, Near Indian Overseas Bank
Kanpur Nagar
UTTAR PRADESH |
7906261455
drortho2711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF THE PRAKHAR HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
aromatic coconut oil |
A placebo comprising of fragrant coconut oil will be used. |
| Intervention |
Gogo Pain Relief & MSM |
The test product Gogo Pain Relief & MSM (M) is a blend of extracts/oil from Gaultheria Procumbens (Wintergreen), Lavandula Angustifolia, Aniba Rosaeodora, Anthemis Nobilis, Eucalyptus Globulus, Rosmarinus Officinalis, Mentha Piperita, Syzygium Aromaticum and Ocimumbasilicum. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must be adults, aged at least 35 to 80 yrs old with radiographically established OA.
2. At screening, subjects must complete questionnaires that would provide investigators with information on their medical and OA history and demographics. Pain level in the last week will be evaluated using the Visual Analog Scale (VAS) and functionality in activities of daily living with the Western Ontario and McMaster Universities Osteoarthritis Index.
3. Females Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
4. Subjects should be having a pre-randomization score of 40 to 90 on the Western Ontario and McMaster Universities Osteoarthritis Index.
5. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
6. Participants must be willing to apply the test product and return for assessment visits for evaluation.
7. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications that has not been recommended by the study physician.
|
|
| ExclusionCriteria |
| Details |
1. Participants with rheumatoid arthritis; fibromyalgia; recurrent or active pseudogout, cancer, or other serious medical conditions
2. Single or married subjects who are pregnant or have borne children in past one year.
3. Participants with a history of signs or history of kidney or liver failure OR asthma requiring use of corticosteroids OR use of oral corticosteroids within the past 4 weeks
4. Participants with a history of intra-articular knee depo corticosteroids within the previous 3 months, or intra-articular hyaluronate within the previous 6 months.
5. Participants with evidence or history of medical or surgical event in the past year that may significantly affect the study outcome such as arthroscopy of the knee within the previous year; significant injury to the knee within the previous 6 months; or a rash or open wound over the knee.
6 Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician.
7. Participant with known allergies to the main components of the test product or placebo.
8. Participation in another clinical trial or taking an investigational product in the past three months
9. Any participant who is not able to give informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Criteria for efficacy are:
1. A negative change in WOMAC scores from baseline indicating improvement of symptoms and limitations; as compared to the placebo (WOMAC assesses pain, stiffness and physical functional disability using a series of 24 questions).
2. Negative change in the VAS score assessing pain
3. Range of motion in degrees. X-ray will be done both at baseline and at the end of the treatment to evaluate the benefit of the treatment.
|
Day 0
Day 30
Day 60
Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary endpoints comprise of the safety analyses i.e Adverse events including SAEs. |
Day 0
Day 30
Day 60
Day 90 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/11/2018 |
| 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="1"
Months="2"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be done after study completion as per Sponsor requirement |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study
will enrol adults aged between 35-65 years that have diagnosed with OA based on
radiographic evidence. Eligible
participants screened in baseline interview will be randomized into two groups
to be treated with either the test product Gogo Pain Relief & MSM (M) or comparator. The baseline interview will collect
sociodemographic data pain level in the last week using the Visual Analog Scale
(VAS) (0= no pain; 10= worst pain ever), and functionality in activities of
daily living with the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC). An X-ray of the affected area will be done for the baseline
assessment and at the end of treatment to evaluate the efficacy of the
treatment. In addition to the test product/ placebo, a standard treatment
prescribed by a physician will be given to the patients with osteoarthritis.
Subjects
will be evaluated at the end of first (Day 30), second (Day 60) and third month
(Day 90) (assessment visits) regarding pain and functional state, subsequent to
the initiation of treatment. Safety analyses will be done at each visit.
|