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
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Primary Objective of the study is to
- 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.
30 patients will be randomly selected in 2 groups of 15 patients each.
One suppository of Diclofenac Sodium in the dose of 100 mg, 12 hourly, through rectal route, as Control Drug in Group I
One Gudavarti of Trailokya Vijaya Vati in the dose of 125 mg, 12 hourly, through rectal route as Trial Drug in Group II
Method of administration of the studied drugs
Rectal route as Gudavarti / suppository.
After the operative procedure and withdrawal of anesthetic effect of spinal/ general anesthesia suppository of Diclofenac sodium and Gudavarti of Trailokya vijaya vati will be administered in left lateral position, in the patients of Control group and Trial group respectively.
The clinical evaluation in this study will involve assessing the drug’s analgesic properties at 30 minutes, 1.5 hour, 3 hours, 6 hours, 12 hours, and 24 hours based on subjective parameters.
The trial patients will be monitored for any adverse effects during their inpatient stay or at the one-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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.
2. To substantiate the analgesic action of Trailokya Vijaya Vati for post-operative pain management, as a rectal analgesic drug (Gudavarti).
时间窗: 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.
3. To determine onset of analgesic action of Gudavarti of Trailokya Vijaya Vati based on subjective criteria.
时间窗: 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.
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.
时间窗: 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.
次要结局
- 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.)
研究者
Prof Anil Dutt
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola