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临床试验/CTRI/2024/05/067267
CTRI/2024/05/067267已完成3 期

A Randomized Controlled Trial To Evaluate The Efficacy Of Shigru- Nirgundi Ghan Capsule In Postoperative Pain W.S.R. To Raktarsha

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
overall improvement in post operative ano rectal pain using ayurvedic

研究概览

简要总结

Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will

be selected.

All the participants who voluntarily agree to participate and provide informed written

consent for participation will be recruited in the study.

Total 30 participants will be selected after details examination and divided in 2 group of 15 patients

each as per study protocol.

All Procedures will be executed done under aseptic condition.

Patient will not be taken under follow up

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing surgical intervention for raktarsha of age between 16 – 60 years irrespective of gender, religion etc.
  • Patients not requiring to be kept nil via mouth in postoperative period.
  • Willing to participate in the study.
  • Patient planned for arshabandhan technique(plication of hemorrhoidal mass) for bleeding piles.

排除标准

  • patients with antihypertensive,lipid lower medicines,thyroid disorders.
  • Patients requiring concomitant medication for other diseases in postoperative period particularly for pain management Patients habitual of using alcohol or other drugs.
  • Patients having known allergies to trial drugs.
  • All other surgical methods other than plication for bleeding hemorrhoids.

结局指标

主要结局

overall improvement in post operative ano rectal pain using ayurvedic

时间窗: pain assessment will be carried out 8 hourly for 5 days after operation.

intervention with comparison to diclofenac capsules

时间窗: pain assessment will be carried out 8 hourly for 5 days after operation.

次要结局

  • assessment of patient satisfaction after surgical procedure(After post operative 5 th day.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Aishwarya PR

National Institute Of Ayurveda, Deemed To Be University (De-Novo)

研究点 (1)

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