| CTRI Number |
CTRI/2020/06/025601 [Registered on: 04/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of a pain relief formulation RHULEAVE-K in Adults with Exercise Induced Acute Musculoskeletal Pain. |
|
Scientific Title of Study
|
A Randomized Placebo Controlled Double Blinded Multicenter Study to Assess the Efficacy of RHULEAVE-K in Adult Subjects with Exercise Induced Acute Musculoskeletal Pain |
| Trial Acronym |
MSP232 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
DGM, Research and Development |
| Affiliation |
Arjuna Natural Private Ltd (formerly Arjuna Natural Ltd) |
| Address |
Arjuna natural Pvt Ltd Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
DGM, Research and Development |
| Affiliation |
Arjuna Natural Private Ltd (formerly Arjuna Natural Ltd) |
| Address |
Arjuna natural Pvt Ltd Bank Road, Aluva
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
DGM, Research and Development |
| Affiliation |
Arjuna Natural Private Ltd (formerly Arjuna Natural Ltd) |
| Address |
Arjuna natural Pvt Ltd Bank Road, Aluva
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt Ltd, Bank Road, Aluva |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Ltd |
| Address |
Arjuna Natural Pvt Ltd, Bank Road, Aluva |
| Type of Sponsor |
Other [Nutraceutical company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KareSanjeev Kumar |
Government Medical College & General Hospital |
Department of Ortho
Hudco Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH |
7702288992
drsanjeevkumarkare@yahoo.com |
| Dr Ajay Gupta |
Nirmal Hospital |
Department of Ortho
Opp. MLB Medical College, gate no. 3,Jhansi-284128
Jhansi
Jhansi
UTTAR PRADESH |
9005665599
ajaygupt70@yahoo.com |
| Dr Girish |
Rajalakshmi Hospital |
21/1, Lakshmipura Main Road, Vidyaranyapura Post,560097
Bangalore
KARNATAKA |
9845516613
girirudra@yahoo.co.in |
| DrSanthosh Saklecha |
Santosh Hospital |
6/1, Promenade road, Behind coles Park, bangalore - 560005
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
| Dr Siddhartha Singh |
Sudbhawana Hospital |
Department of General medicine, B31/80-23B, bhogabir, Lanka, varanasi-221005
Varanasi
UTTAR PRADESH |
9415262714
dr.siddharthasingh@gmail.com |
| Dr Meghana Murthy |
Vagus Hospital |
8,4th Main Rd, Malleshwaram,560003
Bangalore
KARNATAKA |
917259214727
meggydoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College |
Approved |
| Institutional Ethics Committee Nirmal Hospital |
Approved |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
| Santhosh Hospital Institutional Ethics Committee |
Approved |
| Sudbhawana Hospital Ethics Committee |
Approved |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Excercise induced musculoskeletal pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
500 mg capsules (Maltodextrin, polysorbate-80, propylene glycol, PEG400) twice daily as single dose. |
| Intervention |
RHULEAVE-K |
500 mg capsules (Turmeric Extract 95% (28%), Boswellia serrata extract 10%) twice daily as single dose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult subject, Male or female between 18-65 years of age.
2.A score of 5cm or above on the NRS ( at rest).
3.Subjects having Exercise Induced Acute Musculoskeletal Pain which occurred within 24 hours before presentation. (musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 sprain or strain), not requiring admittance to hospital.
4.Willing to give voluntary informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management of acute injuries of ligaments, tendons, or muscles, painful complicated acute soft tissue injury of the upper or lower extremity, including. Subjects with Grade 2 & 3 sprain or strain or Muscle cramps due to dehydration.
2.Subjects with known history of osteoarthritis and rheumatoid arthritis.
3.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
4.Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
5.Subjects underlying dermatitis or dermatosis associated with the injury.
6.Use of any oral or topical analgesic, antipyretic, sedative or anti-inflammatory treatment, Use of any topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetic products at the site of pain within 1 week prior to study or during the study.
7.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation.
8.Any kind of neuralgic pain, headache and/or chronic pain
9.Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
10.A known pregnancy or lactation
11.Previous history of gastro-intestinal haemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding.
12.Subjects who are severe smokers and drinkers
13.Received an investigational product or participated in an investigational study within a period of 30 days prior to receiving study medication.
14.Scheduled elective surgery or other invasive procedures during the period of study participation.
15.Subjects had a history of diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV, HIV).
16.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SPID6 (Sum of Pain intensity difference) using NRS (at rest) |
Time Frame: each 30 min post-dose censored at 6hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Earliest onset of analgesia (perceived pain relief and meaningful pain relief) |
From post-dose to censored at 6hrs |
| SPID6 (Sum of Pain intensity difference) using NRS (at movement and pressure) |
Time Frame: each 30 min post-dose censored at 6hrs |
| TOTPAR6 (Total Pain Relief) 4. PRS (at rest, movement and pressure) |
each 30 min post-dose censored at 6hrs |
| McGill Short Form Questionnaire |
Screening and after 6h. |
|
|
Target Sample Size
|
Total Sample Size="232"
Sample Size from India="232"
Final Enrollment numbers achieved (Total)= "232"
Final Enrollment numbers achieved (India)="232" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/06/2020 |
| Date of Study Completion (India) |
21/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The potential participants who are willing to provide a written informed consent form will be asked to come for screening. The main inclusion criteria of the screening procedure will be an NRS score (at rest) of 5 or above. McGill –SFQ will also be taken at the screening which will be considered as the baseline score. The subjects will be asked specific history of pain like date of occurence, time of onset, duration of pain, part of the body affected, history of similar pain in the past during exercise (<24h, 24-48h, >48h), its severity, duration of pain, any treatment taken etc. Any underlying condition which will affect the current pain or evaluation of treatment will be sought for and excluded by history and physical examination. The participants will then be randomized into either the treatment group or the placebo group.
Post dose for every 30 minutes interval up to 6hrs the participant will be asked to indicate their resting pain intensity and pain relief, and also their pain on movement and pressure using the NRS and PRS scale. McGill-SF questionnaire will be taken at the end of the study to evaluate quality of pain. |