Clinical study to find out the safety and efficacy of Injection Harsha 22, a polyherbal anesthetic agent

A multi-centre open label clinical trial to compare the effectiveness and safety of polyherbal Injection Harsha 22 and lignocaine hydrochloride in minor surgical procedures

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049167

Enrollment

180

Registered

2023-01-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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.Timepoint: ain will be assessed in 5 timepoints. Time 1 â?? During initial local anaesthetic injection. Time 2 â?? During the surgical procedure. Time 3 â?? Immediately after the procedure. Time 4 â?? 4 hours after procedure. Time 5 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.Timepoint: ain will be assessed in 5 timepoints. Time 1 â?? During initial local anaesthetic injection. Time 2 â?? During the surgical procedure. Time 3 â?? Immediately after the procedure. Time 4 â?? 4 hours after procedure. Time 5 â?? 24 hours after procedure.

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Secondary

Measure	Time frame
1. Evaluation of Safety parameters of the Injection Harsha 22 by assessing LFT, RFT, CRP. 2. Assessing unusual oedema/inflammation, delayed wound healing and wound infection. 3. To find out the other therapeutic properties. 4. Finally, to access the pharmacoeconomical feasibility of Injection Harsha 22 when compared to that of SOC. Timepoint: Time 1 â?? Baseline â?? will be assessed before intervention. Time 2 â?? 2 weeks after intervention. Swelling, Delayed wound healing and wound infection will be assessed 2 weeks after intervention.	—

Measure

Time frame

1. Evaluation of Safety parameters of the Injection Harsha 22 by assessing LFT, RFT, CRP. 2. Assessing unusual oedema/inflammation, delayed wound healing and wound infection. 3. To find out the other therapeutic properties. 4. Finally, to access the pharmacoeconomical feasibility of Injection Harsha 22 when compared to that of SOC. Timepoint: Time 1 â?? Baseline â?? will be assessed before intervention. Time 2 â?? 2 weeks after intervention. Swelling, Delayed wound healing and wound infection will be assessed 2 weeks after intervention.

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Countries

India

Contacts

Public ContactDr Shan Sasidharan

Pankajakasthuri Herbal Research Foundation

drshan@pkhil.com09188325339

Outcome results