An interventional study of E-PR-01 and E- PR-02 in Joint Pain, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 1 site in India. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other
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.
The study is a randomized, double-blind, placebo controlled, cross-over study to explore the effect of a product E-PR-01 on joint pain. Approximately 50 participants aged between ≥ 20 and ≤ 60 years will be screened. At least 40 participants will be randomized, and the participants will be crossed over both the IP and placebo arms. A minimum of 32 participants must complete the study, after accounting for the screening failure and dropout /withdrawal rate of 20% each. The duration of each treatment for all the study participants will be 5 days, the washout period between each treatment period being 5 ± 2 days.
The total study period from the first start of treatment visit, inclusive of the washout and treatment periods, is estimated to be 15 days.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 40 is below the median of 63 across 219 interventional studies indexed under Arthralgia.
Browse Arthralgia studies →Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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 with heavy alcohol consumption, defined as For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
For women: More than 7 SAD/week or more than 3 SAD in a day.
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
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
Active arm
Placebo arm
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..
Time frame: From baseline Day 1 for both treatment period
Pain Intensity Difference (PID)
In this study, the Pain VAS will be used as the method of pain intensity assessment. The values of Pain VAS measured right after IP consumption and each specified time intervals will be the value used to assess PID.at 2-, 3- and 4-hours Day 1 as compared to placebo. Minimum score is 0 represent No pain and 100 means worst possible pain.
Time frame: 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
VAS score will be taken at 0-hour post exertion and at 4 hours post IP consumption after the performance of the modified Naughton Protocol. The summation of the PID values obtained will be used to calculate the sum of Pain Intensity Difference (SPID). Minimum score is 0 represent No pain and 100 means worst possible pain. SPID (ti-ti+n) = ∑ (PIDi)\*(ti+1-ti)
Time frame: 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
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Vedic Lifesciences Pvt. Ltd.