THERAPEUTIC EVALUATION OF A UNANI PHARMACOPOEIAL FORMULATION – DAWA-E-GURDA IN HASĀH AL-KULYA (NEPHROLITHIASIS): A SINGLE ARM, OPEN LABEL, PROSPECTIVE CLINICAL STUDY
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1) Stone Size on Ultrasound (KUB)
研究概览
简要总结
HasÄh al-Kulya (Nephrolithiasis), or kidney stone disease, is a common,
painful condition, having a substantial economic impact. Each year,
billions of dollars are spent on the nephrolithiasis-related activity, with the
majority of expenditures on surgical treatment of existing stones.
Infectious stones, if not appropriately treated, can have devastating
consequences and lead to end-stage renal disease. Globally, its
incidence is increasing; an analysis from India shows an increase from
0.9% to 9.0% over 20 years. Once an individual has had a stone, the
prevention of a recurrence is essential. 1
The goals of nephrolithiasis treatment are to remove the stone, reduce the
3
damage incurred by growth and spread of stones, and prevent its
recurrence. Therapies in modern system of medicine for expulsion and
prevention of recurrence of nephrolithiasis are ineffective. Certain drugs
may help the stone to pass, but they have frequent and serious adverse
effects.
Treating nephrolithiasis with thiazides may induce hypokalaemia,
hypomagnesaemia, hyperuricaemia, hyperglycaemia, and
hyperlipidaemia. Thiazide-induced hypokalemia will reduce urine citrate,
an important inhibitor of calcium crystallization (secondary
hypocitraturia), and leading to stone formation. Moreover, the drug
(thiazide) effect requires a slight contraction of the extracellular fluid
volume, and high dietary NaCl intake reduces its therapeutic effect.
Acetohydroxamic acid, an inhibitor of urease is used to treat struvite
stones, but it has many side effects, such as headache, tremor, and
thrombophlebitis, that limits its use. Although penicillamine or tiopronin
are effective in the treatment of cystine stones, but the ability of these
treatments to reduce stone frequency is not quantitatively known.
However, they exhibit a high rate of intolerance due to severe side
effects, such as abdominal pain, loss of taste, fever, proteinuria, and,
nephritic syndrome. Allopurinol is used in calcium and uric acid stones,
but it inhibits xanthine oxidase leading to xanthine stone formation. 2
Currently, surgical procedures and extra-corporeal shock wave lithotripsy
(ESWL) are commonly employed in the management of nephrolithiasis.
With lithotripsy, residual stones are left in 35-50% of cases having
stones of >2 cm, or >1 cm in the lower poles; and lithotripsy disrupts
cystine stones poorly. 2 Moreover, the major drawback of these
procedures is a recurrence of renal calculi. Most of the patients who
undergo a surgical procedure for removal of renal calculi refuse to undergo
a similar procedure again and again. For them, drugs that would remove
renal calculus and would prevent recurrence are required.
Unani drugs having lithotriptic activity as such may not replace surgically
procedures but may help in preventing the recurrence of nephrolithiasis.
Unani Pharmacopoeial formulation – Dawa-e-Gurda has been used by
the Unani physicians since decades for the treatment of HasÄh al-Kulya
(Nephrolithiasis), but no scientific data regarding its safety and efficacy
are available. Keeping this in view, this study has been planned to
evaluate the safety and efficacy of an Unani Pharmacopoeial formulation
– Dawa-e-Gurda in the treatment of HasÄh al-Kulya (Nephrolithiasis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of any sex aged 18-65 years 2) Patients with HasÄh al-Kulya (nephrolithiasis) diagnosed by Plain X-Ray Abdomen (KUB)/ Ultrasound Abdomen 3) Stone in Renal Pelvis with size ranging from 5-9 mm 4) Patients with or without any of the following symptoms: -Bawl al-Dam (Haematuria) -Siql al-KhÄsira (Heaviness in the Loin) -Waja‘ al-KhÄsira (Pain in the Loin) -Urine showing Calcium Crystalluria -History of Recurrent UTI -History of Recurrent Nephrolithiasis 5) Patients willing to give written informed consent 6) Patients willing to comply with the requirements of the study protocol.
排除标准
- •Patients aged less than 18 or more than 65 years 2) Patients having acute renal colic 3) Complicated cases of nephrolithiasis requiring surgical intervention 4) Patients with hydronephrosis, acute symptoms of UTI or any other kidney disease, including serum creatinine level more than 1.5 x ULN or eGFR less than 60 mL/min 5) Liver dysfunction, defined as serum bilirubin more than 1.5 x ULN, SGOT (AST) or SGPT (ALT) more than 2.5 x ULN 6) Known cases of significant cardiac/ pulmonary dysfunction or immunocompromised states (HIV/ AIDS, etc.)/ malignancies 7) Patients on long-term medications 8) Pregnancy and lactation 9) Currently active alcohol or drug abuse/ history of alcohol or drug abuse within 6 months prior to baseline 10) Known sensitivity to study medication or any of its ingredient 11) Patient not willing to attend treatment schedule regularly.
结局指标
主要结局
1) Stone Size on Ultrasound (KUB)
时间窗: USG at Baseline and 8th week. | Rest at Baseline, 2nd week, 4th week, 6th week, 8th week
2) Renal Pain and Loin Heaviness
时间窗: USG at Baseline and 8th week. | Rest at Baseline, 2nd week, 4th week, 6th week, 8th week
3) Visual Analogue Scale (VAS)
时间窗: USG at Baseline and 8th week. | Rest at Baseline, 2nd week, 4th week, 6th week, 8th week
4) Relief in Bawl al-Dam (Haematuria)
时间窗: USG at Baseline and 8th week. | Rest at Baseline, 2nd week, 4th week, 6th week, 8th week
次要结局
- Lab Investigations(Baseline and after treatment.)