A study to see if Pain Klear is safe and works well for people with sudden pain.

An Open-Label, Single-Arm, Single-Center, Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Pain Klear in Patients with Acute Pain. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087142

Enrollment

Registered

2025-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and above, male or female 2. Diagnosis of acute pain such as low back pain, musculoskeletal strain, tendinitis, migraine, dental pain, or trauma-related pain 3. Pain intensity score of 5 or more on the 11-point Numeric Rating Scale at screening or baseline visit Medically stable as assessed by the investigator 4. Able and willing to provide written informed consent before study procedures 5. Willing to follow all study procedures, visit schedules, and use of investigational product as per protocol

Exclusion criteria

Exclusion criteria: 1. Known allergy or sensitivity to the study medicine or any of its ingredients 2. Use of pain relief medicines like NSAIDs or opioids within 24 hours before screening 3. History of stomach bleeding, ulcers, or similar digestive problems 4. Uncontrolled heart-related health problems 5. Kidney problems with serum creatinine level more than 2 point 5 mg per dL 6. Pregnant or breastfeeding women, or women who are not using proper birth control 7. Taking part in another clinical trial or used any investigational product in the past 30 days 8.Not willing or not able to give consent or follow the study rules

Design outcomes

Primary

Measure	Time frame
1. To evaluate the change in pain intensity from baseline to the end of the study on Day 20 plus or minus 2 days using the 11 point Numeric Rating Scale where 0 means no pain and 10 means worst imaginable pain 2.A clinically significant response will be defined as a reduction of 2 or more points on the scale or a reduction of 30 percent or more from baseline based on IMMPACT guidelinesTimepoint: Day 0, Day 10, Day 20	—

Measure

Time frame

1. To evaluate the change in pain intensity from baseline to the end of the study on Day 20 plus or minus 2 days using the 11 point Numeric Rating Scale where 0 means no pain and 10 means worst imaginable pain 2.A clinically significant response will be defined as a reduction of 2 or more points on the scale or a reduction of 30 percent or more from baseline based on IMMPACT guidelinesTimepoint: Day 0, Day 10, Day 20

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Secondary

Measure	Time frame
1. Time to Onset of Pain Relief Time from first dose to patient self-reported initial perception of pain relief Expected range is 15 to 60 minutes after dose Collected through subject diaries and clinician assessment 2. Duration of Pain Relief Defined as the continuous time during which the subject reports sustained pain relief with NRS less than or equal to 3 after onset Expected duration is 4 to 12 hours depending on the mechanism of action of Pain Klear Captured through subject diary and confirmed by study staff 3. Change in Quality of Life Measured using the SF 36 Health Survey which assesses 8 health domains Scores range from 0 to 100 for each domain where higher score indicates better quality of life Endpoint is improvement of 5 to 10 points in physical functioning and bodily pain domains from baseline to Day 20Timepoint: Day 0, Day 10, Day 20	—

Measure

Time frame

1. Time to Onset of Pain Relief Time from first dose to patient self-reported initial perception of pain relief Expected range is 15 to 60 minutes after dose Collected through subject diaries and clinician assessment 2. Duration of Pain Relief Defined as the continuous time during which the subject reports sustained pain relief with NRS less than or equal to 3 after onset Expected duration is 4 to 12 hours depending on the mechanism of action of Pain Klear Captured through subject diary and confirmed by study staff 3. Change in Quality of Life Measured using the SF 36 Health Survey which assesses 8 health domains Scores range from 0 to 100 for each domain where higher score indicates better quality of life Endpoint is improvement of 5 to 10 points in physical functioning and bodily pain domains from baseline to Day 20Timepoint: Day 0, Day 10, Day 20

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Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results