Clinical study to find out the safety and efficacy of a polyherbal local anaesthetic parenteral formulation

A Multi-centre Open label Phase II clinical trial to compare the effectiveness and safety of local anaesthesia by polyherbal local anesthetic injection and lignocaine hydrochloride in minor surgical procedures

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043126

Enrollment

Registered

2022-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Subjects indicated for minor surgical procedures under Local anaesthesia; Willing to enroll in the study by signing the informed consent.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to any one of the ingredients in the polyherbal local anaesthetic injection, lignocaine hydrochloride or to any local anaesthetic agent of amide type. 2. Uncontrolled hypertension/congenital heart problems. 3. Any chronic illness with life-threatening comorbidities. 4. Impaired cardiovascular and respiratory function. 5. Patients with medicament-induced altered pain perception.

Design outcomes

Primary

Measure	Time frame
1. Primary outcome of the trial is induction of adequate local anaesthetic effect / analgesia for performing a minor surgical procedure. 2. Pain will be assessed using VAS Score from 0 to 10 (0 Ã¢â?¬â?? no pain, 10 Ã¢â?¬â?? most severe pain) Timepoint: Pain will be assessed in 5 timepoints. Time 1 Ã¢â?¬â?? During initial local anaesthetic injection. Time 2 Ã¢â?¬â?? During the surgical procedure. Time 3 Ã¢â?¬â?? Immediately after the procedure. Time 4 Ã¢â?¬â?? 4 hours after procedure. Time 5 Ã¢â?¬â?? 24 hours after procedure.	—

Measure

Time frame

1. Primary outcome of the trial is induction of adequate local anaesthetic effect / analgesia for performing a minor surgical procedure. 2. Pain will be assessed using VAS Score from 0 to 10 (0 Ã¢â?¬â?? no pain, 10 Ã¢â?¬â?? most severe pain) Timepoint: Pain will be assessed in 5 timepoints. Time 1 Ã¢â?¬â?? During initial local anaesthetic injection. Time 2 Ã¢â?¬â?? During the surgical procedure. Time 3 Ã¢â?¬â?? Immediately after the procedure. Time 4 Ã¢â?¬â?? 4 hours after procedure. Time 5 Ã¢â?¬â?? 24 hours after procedure.

—

Secondary

Measure	Time frame
1. Evaluation of Safety parameters of the drug by assessing LFT, RFT, CRP. 2. Assessing unusual swelling, delayed wound healing and wound infection. Timepoint: Time 1 Ã¢â?¬â?? Baseline Ã¢â?¬â?? will be assessed before intervention. Time 2 Ã¢â?¬â?? 2 weeks after intervention. Swelling, Delayed wound healing and wound infection will be assessed 2 weeks after intervention.	—

Countries

India

Contacts

Public ContactDr Shan Sasidharan

Pankajakasthuri Herbal Research Foundation

drshan@pkhil.com09188325339

Outcome results