| CTRI Number |
CTRI/2020/01/022709 [Registered on: 13/01/2020] 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
|
Effect Of A Turmeric-Boswellia Blend In Acute Body Pain |
|
Scientific Title of Study
|
A Randomized Placebo Controlled double blinded Study to Assess the Efficacy of a Turmeric-Boswellia Blend in Adult Subjects with Acute Musculoskeletal Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-01PFT011219H4-WES02 version01 nov 7, 2019 |
Protocol Number |
|
|
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 Private Ltd,
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva
Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| 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 Private Ltd,
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| 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 Private Ltd,
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| Email |
drbinu@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt Ltd, Bank Road, Aluva, Kerala, India - 683101 |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Ltd |
| Address |
Arjuna Natural Private Ltd, Bank Road, Aluva,
Ernakulam |
| Type of Sponsor |
Other [Nutraceutical company] |
|
|
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 |
| DrAshish Kumar Gupta |
Charak Hospital and research centre |
Department of Orthopedics, Ground floor OPD unit, Room Number 9, Hardoi Rd, near Safed Masjid, Dubagga, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
918604833709
ashish.kgmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Charak Hospital and Research Center Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Acute Musculoskeletal Pain within 24 hours |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Maltodextrin,500 mg soft gel capsule x 2 daily for 3 days. |
| Intervention |
Turmeric-Boswellia Blend |
Turmeric extract, Boswellia serrata extract, sesame oil 500 mg soft gel capsule capsule x 2 daily for 3 days |
| Intervention |
Turmeric-Boswellia Blend and Placebo |
Turmeric- Boswellia Blend 500 mg soft gel capsule x 1 and placebo 500 mg soft gel capsule x 1 daily for 3 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 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
3.Subjects having 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, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. 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
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. TOTPAR calculated as the weighted sum of the PRS scores
2. SPID calculated as the weighted sum of the NRS scores |
1. Pain relief score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr.
2. Pain intensity score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Earliest onset of pain relief |
From post-dose to censored at 6hrs |
| McGill Short Form Questionnaire |
Screening, Day 3 post dose |
| Change in Pain relief |
Baseline, Day 3 |
| Change in Reduction of pain intensity |
Baseline, Day 3 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/01/2020 |
| Date of Study Completion (India) |
08/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The potential
participants who are willing to provide a written informed consent form will be
asked to come for screening (Day 1). The main inclusion criteria for the
screening procedure will be an NRS score of 5 or above. McGill –SFQ will also
be taken at the screening which will be considered as the baseline score.
The participants will
then be randomized into either of the three groups on Day 1. The IP
administration is done on the same day after randomization. Post dose for every
30 minutes interval up to 6h the participant will be asked to indicate their
resting pain intensity and pain relief, using the NRS and PRS scale.
The subject will take
the investigational product in the morning on day 2 and will score the pain
intensity and pain relief after 3h in the subject diary given.
On day 3 the subject
will visit the site for end of the study follow up. The subject will consume
the product 3h before reaching the site. NRS and PRS will be measured.
McGill-SF questionnaire will be taken at the site to evaluate quality of pain.
If there is need for
rescue medication, then the subject will record pain intensity before taking
rescue medication and the consumption recorded.
|