| CTRI Number |
CTRI/2022/10/046693 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
14/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of PeaNoc XL tablet use on patient suffering from chronic pain |
|
Scientific Title of Study
|
A Randomized Open-Label Interventional Clinical Study to Evaluate the Safety and
Efficacy of PeaNoc XL tablets on arthritis patients with joint pain and inflammation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RC Satish Kumar |
| Designation |
Co-Ordinator |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Interdisciplinary Institute of Indian
Systems of Medicine, SRM IST
Kattankulathur
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845887 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T M VIJAYAKUMAR |
| Designation |
Associate Professor |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Department of Pharmacy Practice
SRM College of Pharmacy, SRM Institute of Science and Technology
Kattankulathur
603203
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY, KATTANKULATHUR CAMPUS,KANCHEEPURAM,TAMILNADU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mothishwaran B |
| Designation |
Clinical Research Associate |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
Interdisciplinary Institute of Indian System of Medicine (IIISM)
SRM Institute of Science and Technology
Kattankulathur
603203
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY, KATTANKULATHUR CAMPUS, KANCHEEPURAM,TAMILNADU
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
mothishwaran26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metabolic ward, Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre, No:o1, 4th floor,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203. Kancheepuram TAMIL NADU
|
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
29, Guindy, Chennai, Tamil Nadu 600032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
Potheri
SRM Nagar
Kattankulathur
Tamil Nadu 603203
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| R C SATISH KUMAR |
Metabolic ward, Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre |
No:o1, 4th floor,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203. Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9884845887
ayursatish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICALCOLLEGE HOSPITAL RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PeaNoc-XL
(palmitoylethanolamide 400mg and astaxanthin 1mg) |
PeaNoc-XL (palmitoylethanolamide 400mg and astaxanthin 1mg)
Mode: Oral route-After food
Frequency-Morning and Night for three months. |
| Comparator Agent |
Standard Treatment-Tab.Acetaminophen 500mg |
Tab.Acetaminophen 500mg,
Mode: Oral Route- after food-
Frequency: Morning and night for three months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients with DAS 28 (Disease Activity Score) score greater than or equal to
3.2
-Willingness to provide written informed consent to participate in the study.
-Patients understanding the nature and purpose of the study and who are
willing to comply with study procedures. |
|
| ExclusionCriteria |
| Details |
-Patients who are taking other NSAID /Pain killers other than standard drug
-Abnormal results on Liver function test
-Patients with diabetic neuropathy
-Patients with severe renal, hepatic, cardiac, gastrointestinal, neurological,
hematological or respiratory disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hematological investigations: Complete Blood count will be assessed before and after
the study.
2. Biochemical investigations: Serum creatinine, Liver function tests will be assessed
before and after the study.
3. Inflammatory cytokines (IL-1, IL-6, and TNF-α), C - reactive protein (CRP) and
Erythrocyte sedimentation rate (ESR) will be assessed before and after the study.
4. DAS 28 score will be assessed before and after the study. |
06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess adverse drug reactions during the study period
|
06 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2022 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PeaNoc XL Tablet has been used for the treatment of pain, inflammation, etc. Hence it can
be given as add on supplement with the standard drug to improve the treatment efficacy in
the treatment of pain and inflammation in patients with arthritis.
To test our hypothesis, we are attempting to conduct Clinical trial to evaluate the safety
and efficacy of PeaNoc XL tablets on arthritis patients with joint pain and inflammation by
comparing standard and treatment group |