Clinical study for the management of Urolithiasis

Recruiting

Conditions: Urolithiasis

Registration Number: CTRI/2017/03/008096

Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary: In Ayurveda Asmari (Urolithiasis) is well described in Charaka, Susrutha Samhitha with its etiopathogenesis, clinical features, type and prognosis. Vagbhata explained ashmari as one of the Asta maha gada. Asmari has been derived from the â€œAsmanâ€ Sanskrit word which literally means a structure resembling stone. It has been described that due to unwholesome diet and living habits aggravated kapha reaches in urinary tract dries up and forms the calculus and suppression of urge to passing urine resulting in crystallization and precipitate into calculus formation. There is colicky pain in bladder, anorexia, dysuria, fever, physical lassitude, goat like smell in urine and an excruciating pain in the neck of the bladder, scrotum indicate the formation of the urinary calculus. In Vataja variety stone resembles dusky in colour, hard, irregular, rough, nodular and spiny like kadambha flower & Patient feels severe pain, difficulty in passing urine, flatulus and stool. In pittaja variety stone resembles Marking nut seed shape, Yellowish black, blood mixed, honey coloured and patient feels burning sensation, warm feeling over bladder and sucking type of pain. In kaphaja variety stone resembles madhuka puspa in colour, unctuous, large sized like henâ€™s egg & patient feels dysuria, prickling and incising pain and heaviness and cold sensation over bladder region. On this disease a series of clinical Research Trials have been conducted for the evaluation of certain medicinal preparations in different stages of the disease effectively with Hajarulayahuda Bhasma, Pashanabhedadi ghrita, Kulattadi yoga, Vvarunadi kwatha, Pashanabhedadi kwatha, Ashmari hara kwatha, gokshuradi guggulu etc. This study has been planned to evaluate the efficacy and safety of Shvadamshtradi Kashaya and Hajarulayahuda bhasma. These drugs will be given for 12 weeks. This study will be conducted at OPD of Regional Ayurveda Research Institute for Skin Disorders, Vijayawada.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 75

Inclusion Criteria

1.Patients of either sex with age between 18 and 60 years 2.Patients presenting with or without symptoms of urolithiasis.
3.Radiological evidence of calculi(upto 7 mm) In kidney/ ureter /urinary bladder.

Exclusion Criteria

1.Age below 18 years and above 60 years 2.Calculi size more than 7 mm 3.Impacted calculi 4.Gross hydronephrosis, Pyelonephritis, Renal failure 5.Patients having serum creatinine >1.5 mg/dl 6.Patients who cannot report in person every 2 weeks in the OPD 7.Patients with poorly controlled Hypertension ( >160/100 mmHg) 8.Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 7.5% 9.Patients on medication with any other drugs that may have an influence on the outcome of the study.
10.Known case of cardiovascular diseases 11.Known HIV positive cases 12.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
13.Alcoholics and/or drug abusers 14.H/o hypersensitivity to any of the trial drugs or their ingredients 15.Pregnant/lactating woman.
16.Patients who have completed participation in any other clinical trial during the past six months.
17.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiological disappearance or reduction of calculi size	12 weeks

Secondary Outcome Measures

Name	Time	Method
Relief in Signs & Symptoms of Mutrashmari	12 weeks

Trial Locations

Locations (1): Regional Ayurveda Research Institute for Skin Disorders
🇮🇳
Krishna, ANDHRA PRADESH, India
Regional Ayurveda Research Institute for Skin Disorders
🇮🇳Krishna, ANDHRA PRADESH, India
Dr T Maheswar
Principal investigator
9441415266
mahesh_rri@yahoo.co.in