A CLINICAL STUDY ON AZHAL KALLADAIPPU (RENAL CALCULI)AND THE DRUG OF CHOICCE IS IRUKAARA PARPAM (INTERNAL).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1complete clearance/ reduction in the size of renal calculus in X-ray KUB or USG abdomen.
研究概览
简要总结
Renal calculusor Nephrolithiasis is one of the most common diseases of the renal system. Itoccurs more frequently in men than in women and in whites than in blacks. It israre in children. Urinary calculusis a stone-like body composed of urinary salts bound together by a colloidmatrix of organic materials. It consists of a nucleus around which concentriclayers of urinary salts are deposited. Nephrolithiasis occursin all parts of the world, with a lower lifetime risk of 2-5 percentages inAsia, 8-15 percentages in the West, and 20 percentages in Saudi Arabia.[9].
In India,the incidence of upper and lower urinary tract calculiis more. With its multifactorial etiology and high rate of recurrence, urinarytract stone disease becomes a medicalchallenge. The new approach in diagnosis and management like Extra-corporealshock wave lithotripsy (ESWL) and endoscopy surgery are not cost effective tothe lower socio- economic groups, who are mostly affected by urinary calculus,[2]when compared to the treatment with traditional system of medicine, which iscost effective.its give me a motivation to do a study on IRUKAARA PARPAM in thetreatment of azhal kalladaippu.
In the text Siddha vaithiya Patharthagunavilakkam-Thaathu Jeeva Vaguppu ‘IRUKAARAPARPAM†a Siddha formulation has been specificallyindicated for kalladaippu. The mode ofpreparation seems to be simple and cost effective.The main ingrediants of the above said formulation are vengaram (borax)and padikaaram( alum). Vengaram(Borax) is well known for its karkaraichi(lithotriptic),Siruneerperukki(diuretic) and Azhukalakatri (antiseptic) actions as per Siddhaliterature[15]. Padikaaram (Alum) has Isivakatri(antispasmodic),Azhukalakatri(antiseptic)and Kuruthi pokkadaki(haemostatic) actions as per Siddha literature[16].
The above said drug formulationhas not yet undergone any safety studiesand yet to be documented clinically. Hence I have selected the siddhaformulation “ IRUKAARA PARPAM†for further clinical evaluation in AZHALKALLADAIPPU.
IRUKAARA PARPAM
METHOD OF PREPARATION:
INGREDIENTS:
- Purified Vengaram - 1palam(35gms)
- Purified Alum - 1palam(35gms)
- Lemon juice - Required quantity
- PURIFICATION OF TRIAL DRUGS**:**
- 1**.Vengaram:**
Purification will be done byfrying the Vengaram in a mud vessel until the water content evaporates.
- 2**.Padikaaram:**
Alumwill be mixed well with water and willbe filtered. The filtrate will be boiled again and allowed to cool.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients who are having the classical symptoms of abdominal pain and distensión, pain from loin to groin, pain in urethra, agonizing pain, dysuria, oliguria, yellow coloured urination, burning micturition, haematuria, nausea and vomiting.
- •â€¢Stone size: ≥4mm and ≤10mm •Patient with renal calculus detected on X-ray KUB or USG abdomen.
- •â€¢History of Recurrence of Renal calculi.
- •â€¢Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 24days but can opt out of the trial of his/her own conscious discretion.
- •â€¢Patients who are willing to take Ultrasonography Investigation (USG- abdomen / KUB) and provide blood and urine samples for laboratory investigation.
排除标准
- •â€¢Stone size 10mm •Pregnancy and lactation •Presence of any associated severe systemic illness, e.g.CA •Patient taking any other lithotriptic agent in the recent past •History of Diabetes/ Hypertension •Renal diseases •Cardiac diseases.
结局指标
主要结局
1complete clearance/ reduction in the size of renal calculus in X-ray KUB or USG abdomen.
时间窗: 24 DAYS
次要结局
- 2.Complete reduction of clinical symptoms and improvement in the lab investigation(24DAYS)