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临床试验/CTRI/2017/08/009407
CTRI/2017/08/009407进行中(未招募)2 期

To Evaluate the efficacy of Unani medicines Tukhm-e-Karafs(Apium graveolans Linn)and Tukhm-e-Duqu (Peucedanum grande C.B.Clarke) in the management of Sangi Gurda wa Masana(Urolithiasis) in a clinical study.

Govt Nizamia Tibbi College Hyderabad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月5日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Symptomatic relief from clinical symptoms of urolithiasis

研究概览

简要总结

This study is open, non randomized and****non comparative clinical trial to asses the safety and efficacy of unani medicine Tukmi Karafs(Apium graveolans) and Tukmi Duqu(Peucedanum grande) in patients with HasÄh al-Kulya wa Masana(Urolithiasis).The patients were selected from OPD of Govt. Nizamia General Hospital Charminar. After screening, the 30 patients  of established Urolithiasis were enrolled according to inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks for subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory investigations(Routine and specific)  will be conducted at the initiation and on the completion of the protocol therapy. The drugs selected for trial were identified, authenticated and standardized at Central Research Institute in Unani Medicine(CRIUM) Hyderabad.The drugs will be given to the patients in the powder form in the dosage of 4gm per day in two divided doses.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with established Sangi Gurda wa Masana (Urolithiasis) proved by radiological or sonological investigations.
  • 2.Hematologic and Biochemical parameters within normal limits.
  • 3.Patients with normal liver and kidney function.
  • 3.Patients willing to continue whole period of trial with their written consent.

排除标准

  • 1.Patients with impaired liver and kidney function.
  • 2.Patients with urolithiasis causing obstruction needing emergency management.
  • 3.Patients already on some medication for urolithiasis.
  • 4.Pregnant and lactating women.
  • 5.Patients unwilling to provide informed consent or abide by the requirements of the study.

结局指标

主要结局

Symptomatic relief from clinical symptoms of urolithiasis

时间窗: 06 weeks

次要结局

  • Reduction in size of stone or expulsion of stone by viewing ultrasonological impression.(06 weeks)

研究者

发起方
Govt Nizamia Tibbi College Hyderabad
申办方类型
Other [Govt. Nizamia Tibbi College Charminar Hyderabad]

研究点 (1)

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