| CTRI Number |
CTRI/2021/07/034542 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Phase IV Post-Marketing Surveillance Study to Measure the Efficacy and Safety of Dr.Ortho Pain Relief Oil in Subjects Suffering from Acute Sports Injury, Knee Pain, Stiffness in Joints, Lower Back Pain, Neck Rigidity, Backache and Inflammation in Joints |
|
Scientific Title of Study
|
A Single Centric, Open-Label, Non-Randomized Phase IV Post-Marketing Surveillance Study to Measure the Efficacy and Safety of Dr.Ortho Pain Relief Oil in Subjects Suffering from Acute Sports Injury, Knee Pain, Stiffness in Joints, Lower Back Pain, Neck Rigidity, Backache and Inflammation in Joints |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lokesh Holagundi |
| Designation |
Orthopaedic Surgeon |
| Affiliation |
Health India Hospital |
| Address |
#7, 6th Cross, Chikka Adugodi, Tavarekere Main Road, Near Forum Mall, Bangalore-560029
Bangalore KARNATAKA 560029 India |
| Phone |
7760628844 |
| Fax |
|
| Email |
Loksdoc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vijay Kimtata |
| Designation |
Scientific Medical Reviewer |
| Affiliation |
Divisa Herbal Care |
| Address |
SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India
Chandigarh CHANDIGARH 160009 India |
| Phone |
9816333352 |
| Fax |
|
| Email |
vijaykimtata.vk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd |
| Address |
#252, 13th Cross, Wilson Garden, Bangalore-560027
Bangalore KARNATAKA 560027 India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Divisa Herbal Care
SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump. Madhya Marg, Chandigarh-160009, India |
|
|
Primary Sponsor
|
| Name |
Divisa Herbal Care |
| Address |
SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump. Madhya Marg, Chandigarh-160009, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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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 Lokesh Holagundi |
Heath India Hospital |
#7, 6th Cross, Chikka Adugodi, Tavarekere Main Road, Near Forum Mall, Bangalore-560029 Bangalore KARNATAKA |
7760628844
Loksdoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: Acute Sports Injury, Knee Pain, Stiffness in Joints, Lower Back Pain, Neck Rigidity, Backache and Inflammation in Joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr. Ortho Oil |
5 to 10 ml of topical application of Dr. Ortho oil and gently massage the affected area twice a day |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Between 18 - 80 Years
2. Subjects suffering from Knee pain and joint pain and arthritis
3. Willingness to Take part in Study and able to attend all Scheduled Visits
4. Subjects suffering from Acute sports injury, strains, sprain, chronic Arthritis, back pain, knee pain, and other joint pain
|
|
| ExclusionCriteria |
| Details |
1. Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any clinical Trial
2. Not willing to Sign the ICF or give the consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the percentage of subjects with significant symptomatic reduction of joint muscle stiffness, neck rigidity, and backache assessed through Investigator Assessment Scale and Subject Assessment Questionnaires |
Day 1 to day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in the VAS scoring on the successive application as compared to baseline
2.Incidence of any AEs during the study |
Day 1 to day 30 |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
15/07/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Study has been designed to measure the efficacy and safety of Dr. Ortho Pain Relief Oil in subjects suffering from Acute Sports Injury, Knee Pain, Stiffness in joints, Lower Back Pain, Neck Rigidity, Backache and Inflammation in Joints. The Study is an single centric, open label, Non-randomized, Phase IV Post marketing surveillance study on 120 subjects. There are three visits in the study with one being telephonic follow-up. On screening visit i.e., day 1, the subjects will be screened based on inclusion and exclusion criteria. an informed consent form will be given to all subjects at the screening visit containing all study information in it. Eligible subjects will be enrolled in the study after informed consent procedure and will be briefed about all study related procedure in detail. The site Investigator will explain the subject about all study related process and the visit 2 – Day 15 and Visit 3 Day 30 (Final Visit). All eligible subjects will then be provided with Test Product – Dr. Ortho Oil by Investigator/study coordinator. In the presence of Investigator, the instructions will be given to use the test product at home from Day 1 to Day 30 i.e., 5 to 10 ml of topical application of Dr. Ortho Oil and gently massage the affected area twice a day. Investigator assessment shall be performed on Baseline Day 0 and final visit- Day 30. A self- assessment questionnaire shall be given to all eligible subjects on Baseline- Day 0 and final visit- Day 30. |