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临床试验/CTRI/2023/12/060841
CTRI/2023/12/060841尚未招募2/3 期

A Pharmacognostical Study Of Amlavetas (Garcinia pedunculata Roxb.) Fruit And To Evaluate Its Efficacy In Mutrashmari w.s.r. To Urolithiasis.

Ayurvedic and Unani Tibbia College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Relief in cardinal sign and symptoms (Reduction in pain, burning micturition, hematuria etc) of Mutrashmari (Urolithiasis) on the basis of USG.

研究概览

简要总结

Ayurveda has great antiquity dates back to about 5,000 years B.C. The Materia Medica of Ayurveda comprises of resources of plant, animal, metal and mineral origin, which have been prescribed in therapeutics. WHO has considered traditional system of medicine, as a part of integrated system of medicine. It is reported that traditional systems of medicines are being used since centuries for healthcare by people in countries of the Asia Region as well as in other parts of the world. In recent times, public interest has increased towards traditional medicines for various concerns. Herbal medicines are valuable source of remedies to the people around the world to secure their health.

Ashmari (Urolithiasis), a disorder of Mootravaha Srotasa1, included in Ashtomahagada2 is affecting mankind since antiquity which is manifested due to lack of Sodhana procedures (purification of toxic materials lodged in body parts) and indulging of Apathykari (unsuitable)foods leading to aggravation of Shlesma Dosha which after mixing with urine3, leads to crystal formation known as Sharkara or Sikta (gravels /concretion) which further grows like a stone. This concept of Ashmari formation is understood on one hand as stagnation theory and on the other hand theory of supersaturation/ crystallization (physio-chemical theory) of urine according to modern medicine4.

The incidence of urolithiasis is increasing globally, with geographic, racial, and gendervariation in its occurrence. Positive family history of stone disease, young age at onset, recurrent urinary tract infections (UTIs), and underlying diseases like renal tubular acidosis (RTA) and hyperparathyroidism are the major risk factors for recurrence. High incidence and recurrence rate add enormous cost and loss of workdays.

It has been reported that 12% of the total population are prone to urinary stones. Of this 12%, 50% of the population are severely affected by renal damage, which even leads to a loss of kidneys5. Males are most commonly affected than females with a male to female ratio of 3:1.6 the peak age of developing calculi is between 30-50 years and recurrence is common.

In modern medicine, diuretics, smooth muscle relaxants and non-invasive, invasive surgical procedures are adopted to manage urolithiasis.7 But all kinds of non-invasive, invasive surgical procedures are expensive, therefore not possible to advise for poor people and it will not checkthe recurrence of stone. The medicines including diuretics, alkalizers etc are used to prevent the frequency of hypercalciuria and hyperoxaluria (few etiological factors of calculi formation) but they are not promising enough due to their limited effectiveness and low tolerability.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • kidney Stone Upto 10mm (as measured on USG) Ueteric stone upto 5mm.

排除标准

  • Patients not willing for trial and follow up Chronic Renal failure.
  • Gross Hydronephrosis.
  • Cases which require surgical intervention.
  • Gross Hematuria (>50rbc/HPF).
  • Kidney stone size more than 10 mm Ureteric stone size more than 5 mm Known cases of Malignancy, Tuberculosis.
  • Patients with uncontrolled Hypertension & Diabetes Mellitus.

结局指标

主要结局

Relief in cardinal sign and symptoms (Reduction in pain, burning micturition, hematuria etc) of Mutrashmari (Urolithiasis) on the basis of USG.

时间窗: 3 Months

Evaluation of the drug i.e. Amlavetas [Garcinia pedunculata (Roxb.)] fruit would be assessed on reduction of clinical symptoms of Mutrashmari (Urolithiasis) and improvement in Subjective/Objective parameters as from baseline and after 90 days of therapy.

时间窗: 3 Months

次要结局

  • At the end of the study, five -point Global Assessment scale for efficacy (Cured, Marked improvement, Moderate improvement, Mild improvement, No improvement) will be used.(3 Months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Faizan

Ayurveda and Unani tibbia college Karol Bagh New Delhi

研究点 (1)

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