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Herbal Extract

Bonipar for Chronic Pain

Phase 2
Waitlist Available
Led By Lance Roy, MD
Research Sponsored by Winston Parris, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions

Summary

This trial compares a new herbal pain-relief cream (Bonipar) with an existing medicated cream (diclofenac). It targets patients with muscle and joint pain to see if the herbal cream works as well as the medicated one. Diclofenac is commonly used to treat pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders.

Eligible Conditions
  • Chronic Pain
  • Musculoskeletal Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
Other study objectives
Time to the Onset of Action (the First Feeling of 20% Pain Reduction)

Side effects data

From 2022 Phase 2 trial • 164 Patients • NCT03471507
1%
Head Congestion
1%
Dysesthesia
1%
Pruritus/itching
1%
Mild skin irritation
1%
Abdominal Muscle Spasm
1%
Dysesthesia/Numbness
1%
Rash
1%
Allergies
1%
Rhinorrhea
1%
Sneezing
1%
Altered Gait
1%
Rash on both sides of neck
1%
Headache
1%
Neck pain
1%
Radiating shoulder pain
1%
Lump formation on left thumb
1%
Metallic taste
1%
Tingling toes in treated ankle
1%
Nasal Congestion
1%
Tingling in left hand
1%
Change in blood pressure
1%
Dizziness and increased heart rate
1%
Mild tinnitus
1%
Eye irritation
1%
Diarrhea with blood in the stool
1%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bonipar
Diclofenac Topical Solution 1.5%

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BoniparExperimental Treatment1 Intervention
Group II: Diclofenac topical solution 1.5%Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bonipar
2020
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Winston Parris, MDLead Sponsor
Lance Roy, MDPrincipal InvestigatorDuke University
~33 spots leftby Nov 2025
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