| CTRI Number |
CTRI/2021/07/034635 [Registered on: 06/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACYOF ORTHOHERB OIL |
|
Scientific Title of Study
|
RETROSPECTIVE, CROSS SECTIONAL AND PROSPECTIVE OBSEVATIONAL STUDY TOEVALUATE ORTHOHERB OIL THROUGH POST MARKETING SURVEILLANCE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJHareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation PankajakasthuriAyurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director Research and Development |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college and PG centre Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9188325339 |
| Fax |
|
| Email |
drshan@phkil.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Arun Visakh Nair |
| Designation |
DIRECTOR (SALES & MARKETING) |
| Affiliation |
Pankajakasthuri Herbals India Pvt Ltd. |
| Address |
Pankajakasthuri Herbals India Pvt Ltd.
Poovachal, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695575
India |
| Phone |
9387620301 |
| Fax |
|
| Email |
avnair@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Herbals India Pvt. Ltd, Poovachal, Thiruvananthapuram, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Pankajakasthuri Herbals India Pvt Ltd |
| Address |
Pankajakasthuri Herbals India Pvt. Ltd, Poovachal,Thiruvananthapuram, Kerala, 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 Vijaya R |
Pankajakasthuri Ayurveda Medical College & PG Centre |
Department of Dravyaguna
Room No.1
Pankajakasthuri Ayurveda Medical College & PG Centre,
Killy, Kattakada, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA |
9400093015
vijivijayan5225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M172||Bilateral post-traumatic osteoarthritis of knee. Ayurveda Condition: VATAVYADHIH, (2) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: VATAVYADHIH, (3) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: VATAVYADHIH, (4) ICD-10 Condition:M06||Other rheumatoid arthritis. Ayurveda Condition: VATAVYADHIH, (5) ICD-10 Condition:M173||Unilateral post-traumatic osteoarthritis of knee. Ayurveda Condition: VATAVYADHIH, (6) ICD-10 Condition:M171||Unilateral primary osteoarthritisof knee. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Orthoherb oil |
Applying Orthoherb oil externally at least one time per day |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 35 -70 years
2. Willing to applying Orthoherb oil externally at least one time per day for a continuous period of 6 months
3. Having one or more joint pain
4. Willing to enrol in study by signing Informed consent
|
|
| ExclusionCriteria |
| Details |
1. Earlier participation in this study
2. Subjects using Orthoherb oil since more than two months
3. Pain is of acute onset or due to trauma/injury
4. Unable to respond properly for questionnaire or when a patient is too severely ill to answer the questions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reconfirming the efficacy of Orthoherb oil in joint pain and disorders.
2. Ensuring safety of Orthoherb oil on prolonged use.
3. Incidence of adverse effects or adverse events in users of Orthoherb oil
|
oth-baseline
1st-first response to questionnaire and 2nd -response at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessing additional therapeutic benefits of Orthoherb oil.
2. Reconsider the need of pharmaceutical modification of the product to increase patient compliance if required.
|
oth-baseline
1st-first response to questionnaire and 2nd -response at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
13/07/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aimed to ensure and reconfirm the quality
and efficacy of Orthoherb oil available in the market in different regions of
India, To monitor the safety of Orthoherb oil on prolonged use and To evaluate
the adverse drug reactions (ADR), adverse effects (AE) and additional benefits
reporting by patients. PMS will be conducted as Survey across the subjects by
questionnaire method. Validated Questionnaire covering safety, efficacy,
financial parameters, AE and ADR will be provided to the users of Orthoherb oil.
The data thus gathered will be analyzed through appropriate statistical
methods. |