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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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 



 
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