A clinical trial to evaluate the efficacy of Gudavarti of Trailokya Vijaya Vati, an Ayurvedic Suppository, for Post Operative Pain Management Inguinal Hernia.

A Randomized Controlled Clinical Trial to Evaluate the Comparative Efficacy of Gudavarti of Trailokya Vijaya Vati with Diclofenac Sodium Suppository for Post-Operative Pain Management in Antra Vriddhi W.S.R. to Inguinal Hernia - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065803

Enrollment

Registered

2024-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergone surgery for Inguinal Hernia (Direct, Indirect, Complete, Incomplete) under Spinal Anesthesia/ General Anesthesia Patients who have given informed and written consent to participate in the trial. Age - 20 to 75 years, of either gender. ASA I & II physical status.

Exclusion criteria

Exclusion criteria: Patients of Inflamed / Strangulated/ Obstructed/ Recurrent Inguinal Hernia Patients not falling under the ASA grade-I & II Patients allergic to Trailokya Vijaya Vati or its contents, Diclofenac sodium or other NSAIDs Patients with H/O Drug Addiction, Drug Addicts Patients with bowel incontinence, diarrhea, ano-rectal disorders esp. fissure-in-ano, haemorrhoids or active ano-rectal bleeding. Pregnant / Breast feeding women. Any other condition, which the Principal Investigator thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
1.To compare the effect of Gudavarti of Trailokya Vijaya Vati with established known analgesic suppository of Diclofenac, in Post-operative pain management of Inguinal Hernia. 2.To substantiate the analgesic action of Trailokya Vijaya Vati for post-operative pain management, as a rectal analgesic drug (Gudavarti). 3.To determine onset of analgesic action of Gudavarti of Trailokya Vijaya Vati based on subjective criteria. 4.To compare the extent of pain relief after the use of Gudavarti of Trailokya Vijaya Vati with that of Suppository of Diclofenac Sodium at the end of 24 hours study period.Timepoint: Pain assessment will be conducted at the baseline, prior to the administration of the first dose. Subsequently, pain levels will be recorded at 30-minute interval, and at 1.5-hour, 3-hour, 6-hour, 12- hour, and 24- hour based on subjective parameters for a total of 24 hours. Pain recordings will be conducted prior to the administration of the subsequent dose.	—

Measure

Time frame

1.To compare the effect of Gudavarti of Trailokya Vijaya Vati with established known analgesic suppository of Diclofenac, in Post-operative pain management of Inguinal Hernia. 2.To substantiate the analgesic action of Trailokya Vijaya Vati for post-operative pain management, as a rectal analgesic drug (Gudavarti). 3.To determine onset of analgesic action of Gudavarti of Trailokya Vijaya Vati based on subjective criteria. 4.To compare the extent of pain relief after the use of Gudavarti of Trailokya Vijaya Vati with that of Suppository of Diclofenac Sodium at the end of 24 hours study period.Timepoint: Pain assessment will be conducted at the baseline, prior to the administration of the first dose. Subsequently, pain levels will be recorded at 30-minute interval, and at 1.5-hour, 3-hour, 6-hour, 12- hour, and 24- hour based on subjective parameters for a total of 24 hours. Pain recordings will be conducted prior to the administration of the subsequent dose.

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Secondary

Measure	Time frame
1. To explore the literature, regarding pain and its management through rectal route. 2. To explore the literature, regarding Inguinal Hernia and its surgical management. 3. To study the adverse effects of Gudavarti of Trailokya Vijaya Vati and suppository of Diclofenac Sodium Timepoint: The trial patients will be monitored for any adverse effects during their inpatient stay or at the one-week follow-up.	—

Measure

Time frame

1. To explore the literature, regarding pain and its management through rectal route. 2. To explore the literature, regarding Inguinal Hernia and its surgical management. 3. To study the adverse effects of Gudavarti of Trailokya Vijaya Vati and suppository of Diclofenac Sodium Timepoint: The trial patients will be monitored for any adverse effects during their inpatient stay or at the one-week follow-up.

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Countries

India

Contacts

Public ContactDr ASHISH AWASTHI

Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola

dr_seemanil@yahoo.com8351005225

Outcome results