Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain

NCT05052112 | Completed

• 1 other identifier: EB/210504/VTZO/JP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This Clinical trial study for the effect of a product E-PR-01 will be studied for its ability to attain rapid pain relief in the individuals suffering from exercise-induced knee joint pain, as well as determine its sustained effect on pain reduction over a treatment period of five days.

Conditions

Joint Pain

Outcome Measures

Primary Outcomes (1)

• Time to Meaningful pain relief assed by Visual Analogue scale

  To determine the effect of IP after single dose on time taken to achieve meaningful pain relief as assessed by the time taken to have a reduction of at least 40 % from baseline (0-hour post exertion) on a 100-point pain visual analogue scale as compared to placebo..

  From baseline Day 1 for both treatment period

Secondary Outcomes (2)

• Pain Intensity Difference (PID)

  At Post IP 2 hour, 3 hour and 4 hours Day 1 of treatment 1 and Post IP 2 hour, 3 hour and 4 hours Day 1 of treatment 2

• Sum of Pain Intensity Difference SPID

  at 0-hour post exertion and at 4 hours post IP Day 1 of treatment 1 and 0-hour post exertion and at 4 hours post IP Day 1 of treatment 2

Study Arms (2)

E-PR-01 200mg

ACTIVE COMPARATOR

Oral administration : One capsule to be taken after breakfast and one capsule before dinner for around 5 to 7 days

Other: E-PR-01; Other: E- PR-02

E-PR-02 200mg

PLACEBO COMPARATOR

Oral administration : One capsule to be taken after breakfast and one capsule before dinner for around 5 to7 days

Other: E-PR-01; Other: E- PR-02

Interventions

E-PR-01 OTHER

Active arm

E-PR-01 200mg; E-PR-02 200mg

E- PR-02 OTHER

Placebo arm

E-PR-01 200mg; E-PR-02 200mg

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active adults aged ≥20 and ≤60 years with history of knee joint pain aggravation on physical stress (walking, running, cycling etc.).
• Body Mass Index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
• Participants with self-reported joint pain of ≥ 60 on 100 mm VAS scale after walking on treadmill using modified Naughton's protocol.
• Participants with no or minimal pain at rest (≤ 30 mm on VAS scale).
• Participants willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
• Participants with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.

You may not qualify if:

• Known cases of osteo-, rheumatic- or any other form of arthritis.
• Participants fulfilling ≥ 3 of the following ACR criteria:
• i. Over the age of 50 years ii. Less than 30 minutes of morning stiffness iii. Crepitus on active motion iv. Bony tenderness v. Bony enlargement vi. No palpable warmth at the knee
• Participants suffering from Insomnia and restless leg syndrome.
• Participants with uncontrolled Hypertension, as characterized by Systolic Blood Pressure (SBP) \>139 mmHg and Diastolic Blood Pressure \>89 mmHg.
• Participants currently on anti-hypertensives
• Participants suffering from Type II Diabetes Mellitus.
• Participants with history of lower limb injure in the past six months.
• Participants currently on joint health supplements and medications.
• Participants with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes
• Participants who have used Intraarticular injections in the last six months.
• Participants who have undergone a significant cardiovascular event in the past six months.
• Individuals with history of hyperacidity with at least one episode/ week.
• Individuals with diagnosed cases of migraine.
• History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (1)

Vedic Lifesciences

Mumbai, Maharashtra, 400053, India

Location

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Placebo-controlled, Double-blind, Cross-Over Study

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 22, 2021
• Study Start: September 9, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

IN (1)