| CTRI Number |
CTRI/2023/03/051157 [Registered on: 29/03/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A study to evaluate the effect of Investigational Product on lower back and knee pain in physically active individuals. |
|
Scientific Title of Study
|
A randomized, placebo-controlled, double-blind study
to evaluate the efficacy of E-PR-01 on musculoskeletal health in physically active individuals
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EB/221202/MUV/JP 1.1 May 11, 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Associate Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai 400053, India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Associate Director Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai 400053, India
MAHARASHTRA
400053
India |
| Phone |
02242172300 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Raote |
| Designation |
Assistant Manager Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai 400053, India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172325 |
| Fax |
|
| Email |
sonal.raote@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
B-118, Morya House, Off. New Link Road, Andheri West, Mumbai 400053, India |
| Type of Sponsor |
Contract research organization |
|
|
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 Sagar Karvir |
Ayush Nursing Home |
Gaurav Garden Complex, Row House 5, Gaurav Vista, Bandar, Pakhadi Road, Kandivali West, Mumbai - 400067, Maharashtra, India
Mumbai
MAHARASHTRA |
9821767824
sagarkarvir@gmail.com |
| Dr Surendra Bhasale |
Diamond Hospital |
First Floor, Dattadham Building CHS. Ltd., Opp. Dattadham Mandir, Dahanukarwadi, Kandivali West, Mumbai - 400067
Mumbai
MAHARASHTRA |
9870418984
dr.surendrabhasale.ct@gmail.com |
| Dr Ajinkya Desale |
O2 Clinic |
First floor, Canada Complex, Above Sagar Sweets, College Road, Nashik - 422005
Nashik
MAHARASHTRA |
7666556070
desaleajinkya@gmail.com |
| Dr Kshitij Shah |
Proactive Orthopedic Clinic |
Ground floor Juhu Sagar Juhu Versova Link Rd Kapaswadi Andheri West Mumbai Maharashtra 400053
Mumbai
MAHARASHTRA |
9833040048
drkshitij22@gmail.com |
| Dr Manish Chatte |
Sankalp Hospital |
4 B wing avni heights, opp. suyash hospital, Mumbai Naka, Nashik, Maharashtra 422002
Nashik
MAHARASHTRA |
7378741112
dr.manishchatte88@gmail.com |
| Dr Rohit Nalavade |
Sparsh Hospital |
Plot no. 141, Sai Arcade, Mission Compound, Opposite Orion Mall, Panvel, Raigad- 410206, Maharashtra, India
Raigarh
MAHARASHTRA |
7718984455
nrohit7@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Harmony Ethical Research Committee |
Approved |
| Harmony Ethical Research Committee |
Approved |
| Harmony Ethical Research Committee |
Approved |
| Harmony Ethical Research Committee |
Approved |
| Muktai Hospital Ethics Committee |
Approved |
| Muktai Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal Health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
E-PR-01
(High Dose) |
One capsule twice a day for 90 days |
| Intervention |
E-PR-01 (Low Dose) |
One capsule twice a day for 90 days |
| Comparator Agent |
Placebo
|
One capsule twice a day for 90 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be included in the study if they fulfil each of the below-mentioned criteria:
1. Males & females aged 40-60 years with history of knee and/or low back pain aggravation on physical stress (squatting, walking, running, and cycling) for atleast 3 months and maximum up to 3 years.
2. BMI more than or equal to 24.9 to less than or equal to 29.9 kg/m2.
3. Participants with either of the following two criteria:
a. On screening, low back pain score more than equal to 60 on a 100 point P-NRS after completion of 4 sets of five-repetition-sit-to-stand test along with radiological evidences of lumbo-sacral degeneration indicated by 2 or more of the following:
- Loss of lordosis
- Joint space Narrowing
- Presence of osteophytes
- Bony spurs
b. On screening, knee joint pain score more than or equal to 60 on a 100 point P-NRS after completion of 4 sets of five-repetition-sit-to-stand test along with radiological evidence of knee degeneration indicated by doubtful narrowing of the joint space, possible osteophytes, or definite small osteophytes, definite narrowing of joint space.
4. Participants with a score of less than or equal to 30 on the MSK-HQ scale.
5. Moderate physical activity level as assessed by International Physical Activity Questionnaire (IPAQ)-Short form.
6. Willingness to participate in the study and comply with the study procedures and required visits.
7. Has the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed.
8. Must be literate and have the ability to complete the study-based questionnaires and tasks.
9. Ready to refrain from intake of analgesics one week prior to screening visit and during the study.
10. Female participants of childbearing age must be willing to use the accepted methods of contraception during the study. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded from the study if they fulfil any of the following criteria:
1. P-NRS score more than 40 points on rest.
2. Any other type of pain except joint pain including muscular, nervine or pain due to acute injury.
3. For knee joint, participants with the radiographic evidence of no presence of OA, or multiple moderately sized osteophytes with definite JSN, sclerosis, or definite bony deformity will be excluded.
4. For lumbo-sacral joint, participants with the radiographic evidence of normal, or disc space narrowing with osteophytes, or bone sclerosis, disc space narrowing, and large osteophytes will be excluded.
5. Known cases of osteoporosis.
6. Current intake of disease-modifying osteoarthritis/antirheumatic drugs for joint pain.
7. Participants with neurological characteristic of pain (shooting, burning, stabbing, or electric shock-like pain, tingling, numbness, or a “pins and needles†feeling).
8. Participants suffering from insomnia and restless leg syndrome.
9. Participants with uncontrolled hypertension (defined as SBP more than or equal to 140 mm Hg and/or DBP more than or equal to 90 mm Hg despite anti-hypertensive treatment).
10. Participants suffering from uncontrolled type II diabetes mellitus (RBG ≥200 mg/dl [11.1 mmol/l] despite anti-diabetic treatment).
11. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
12. History of hyperacidity with at least one episode/week.
13. History of use of any dietary supplement within 2 weeks of screening visit.
14. Heavy drinkers defined as - for men, consuming more than 4 drinks on any day or more than 14 drinks per week and for women, consuming more than 3 drinks on any day or more than 7 drinks per weekly.
15. Participants who have any other diagnosed disease or condition, or are using any medication, that in the judgment of the investigator would put him/ her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with intervention or visits.
16. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
17. Participants who have had participated in a study of an investigational product 90 days prior to the screening. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of E-PR-01 (LD and HD) on the musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ) compared to baseline and placebo |
Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain numeric rating scale (P-NRS) score after 2 sets of five-repetition sit-to-stand test compared to baseline and placebo |
Day 90 |
| Range of motion (ROM) of the index joint compared to baseline and placebo |
Day 90 |
| Quality of life (QoL) as assessed by the change in Euro QoL 5 dimension 5 level (EQ-5D-5L) questionnaire score compared to baseline and placebo |
Day 90 |
| Proportion of participants who used rescue medication (RM) during the study compared to placebo |
Day 90 |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="157" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2023 |
| Date of Study Completion (India) |
17/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A study has already been done with this product on participants with low back pain. This study is being done to see the efficacy of the product on low back pain/ knee joint pain in physically active individuals. The study design is a randomized, placebo-controlled, parallel-group, double-blind (double-dummy) study. Approximately 168 participants will be randomized in a ratio of 1:1:1 to receive E-PR-01 (Low Dose), E-PR-01 (High Dose), or Placebo. |