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临床试验/CTRI/2025/03/082881
CTRI/2025/03/082881尚未招募不适用

A randomised clinical controlled study to evaluate the efficacy of Trunpanchmuladi Ghrita in the management of Mutrashmari W.S.R. to Urolithiasis

Dr VJD Gramin Ayurved Mahavidyalaya1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Decrease in symptoms like

研究概览

简要总结

Urolithiasis, commonly known as kidney stones, represent a significant urological health burden globally. These calculi form within the renal system due to the precipitation of substances such as calcium, oxalate, uric acid, and phosphate. The incidence of renal calculi has been steadily rising in recent decades, affecting individuals of all ages and genders, with a notable increase observed in younger populations.

Mutrashmari, as described in Ayurveda, corresponds to renal calculi in modern medical terminology. Ayurveda, offers a holistic approach to healthcare, emphasizing the balance between mind, body, and spirit. The management of Mutrashmari in Ayurveda involves various herbal formulations and lifestyle modifications aimed at not only dissolving the stones but also preventing their recurrence and addressing associated symptoms such as pain and discomfort.

Trunapanchmuladi Ghrit is one such formulation prescribed in Ayurvedic texts for the management of Mutrashmari. It is a medicated ghee prepared using a combination of Kusha, Kasha, Shar, Darbh, Ikshu and Gokshur. Each chosen for its supported therapeutic properties in Ayurveda. These herbs are traditionally believed to possess litholytic (stone-dissolving), diuretic, and anti-inflammatory effects, which are crucial for the treatment of renal calculi and associated urinary tract symptoms.

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
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients showing classical signs and symptoms of Mutrashmari i.e. Renal – ureteric-vesicular calculi as described in Ayurvedic Samhita.
  • Calculi measuring below 10 mm.
  • Patient age between 15-60 yrs .
  • 15 4) Patients from all socio-economic status.
  • Either gender.

排除标准

  • Patients who are not willing.
  • Patients with impending renal failure.
  • Pregnant and lactating women.
  • Patients having age less than 15 years and more than 60 years.
  • Patients having the stone size more than 10 mm in diameter.
  • Staghorn calculus.
  • Severe haematuria.
  • Patients with Diabetes Mellitus, HIV, Hepatitis, TB.
  • Patients with immediate surgical requirement and complications.

结局指标

主要结局

Decrease in symptoms like

时间窗: 7 days, 14 days, 21 days and 28 days after starting treatment

1) Pain at renal angle

时间窗: 7 days, 14 days, 21 days and 28 days after starting treatment

2) Burning micturition

时间窗: 7 days, 14 days, 21 days and 28 days after starting treatment

3) Radiating pain loin to groin

时间窗: 7 days, 14 days, 21 days and 28 days after starting treatment

4) Dysuria of Mutrashmari with reference to Urolithiasis

时间窗: 7 days, 14 days, 21 days and 28 days after starting treatment

次要结局

  • Decrease in symptoms of Mutrashmari(18 months)

研究者

发起方
Dr VJD Gramin Ayurved Mahavidyalaya
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prajot Kokane

Dr VJD Gramin Ayurved Mahavidyalaya

研究点 (1)

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