Evaluation of methi seeds extract in patients with kidney stones

Conditions: Urinary calculus, unspecified, urolithiasis,

Registration Number: CTRI/2013/12/004239

Lead Sponsor: Indus Biotech Private Limited Pune

Brief Summary: Urolithiasis is a common and recurrent disease, impacting the quality of life of the affected individuals. IBHB is a standardized fenugreek extract showed excellent safety profile in toxicological studies. IBHB showed efficacy in animal model of kidney stone in terms of reduced number of crystals and reversal of histological damage to interstitial areas of tubular epithelial cells with significant reduction in tubule interstitial damage index (TDI).

The present double blind, placebo controlled, randomized pilot study objective is aimed at evaluation of efficacy and safety of IBHB (300 mg tablets twice daily) in patients with Urolithiasis for 12 weeks. A total of 100 patients will be randomized to receive test drug or placebo in ratio of 1:1. The primary outcome measure of the study is proportion of subjects with reduction in the size of renal calculus/calculi. Secondary outcome measures are proportion of subjects with reduction in the size and complete expulsion of renal calculus, reduction in the diameter of largest renal calculus, number and sum of diameters of renal calculi, change in the pH of urine and estimated creatinine clearance, change in pain by VAS scores, number, amount of analgesics consumed, QoL by KDQOL-SFâ„¢. Safety outcome measure include number of drop-out subjects, number of patients with UTI, incidences of AEs, physical examination, vital signs and lab parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 80

Inclusion Criteria

Males or females aged 18 to 65 years, both inclusive.2) Symptomatic and asymptomatic cases with radiographic evidence (abdominal USG report up to two weeks prior to screening will be accepted) of diagnosis of renal calculi 3) In case of subjects with multiple calculi, at least one calculus must be 5 mm and all calculi should be 10 mm 4) Subjects willing to refrain from the use of any other herbal treatment for urolithiasis during the entire course of the study 5) Subjects willing to adopt a reliable and effective method of contraception during the course of the study such as abstinence, oral contraceptive pills, barrier method, etc 6) Subjects willing to provide a written informed consent.

Exclusion Criteria

1. Subjects with urinary tract infection 2) Subjects with obstructive uropathy 3) Subjects with known metabolic or endocrinal disorders favouring calculus formation 4) Subjects with known history of hypersensitivity to lactose 5) Subjects with malignancy 6) Subjects with poorly controlled diabetes as observed by a HbA1c of >10% 7) Subjects suffering from chronic systemic illnesses like rheumatoid arthritis,psychoneural-endocrinal disorders, etc necessitating long term therapy 8) Subjects with a history of atrial fibrillation, coronary artery disease, acute coronary syndrome,myocardial infarction, stroke or severe arrhythmia in the past 6 months 9) Subjects with poorly controlled hypertension, as observed by a blood pressure (BP) reading of >160/100 mm Hg in the supine position 10) Subjects on prolonged treatment with corticosteroids, antidepressants, anticholinergics, etc or any other medication that may have an influence on the outcome of the study.
Subjects should not have consumed any of these for at least six weeks prior to screening 11) Subjects with severe hepatic disorder, defined as AST, ALT, total bilirubin, and ALP levels >2 times ULN or renal disorder, defined as serum creatinine levels >1.2 mg/dL 12) Subjects with severe pulmonary dysfunction such as uncontrolled bronchial asthma and/or chronic obstructive pulmonary disease, inflammatory bowel disease, or any other condition which could influence the outcome of the study 13) Subjects who are currently dependent on or abusing, alcohol or one or more of the following: cannabis, cocaine, hallucinogens, inhalants, opioids, sedatives or hypnotics 14) Subjects with known hypersensitivity to the investigational product or its ingredients 15) Subjects with a history of food allergy 16) Subjects with known allergy to diclofenac sodium 17) Subjects who have participated in any other investigational study in the past 6 months 18) Subjects with known HIV, Hepatitis B or Hepatitis C infections 19) Subjects with a positive pregnancy test at screening or who is a lactating female 20) Subjects with any medical condition that in the investigatorâ€™s opinion may threaten the subjectâ€™s ability to complete the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with reduction in the size of renal calculus/calculi as compared to baseline between the groups	At randomization visit (baseline) and at 12 week (end of study)

Secondary Outcome Measures

Name	Time	Method
1)Proportion of subjects with reduction in the size and complete expulsion of renal calculus 2)Reduction in the diameter of largest renal calculus, number and sum of diameters of renal calculi 3)Change in the pH of urine and estimated creatinine clearance 4)Change in pain by VAS scores, number, amount of analgesics consumed 4)QoL by KDQOL-SFâ„¢ 5)Safety in terms of number of drop-out subjects, number of patients with UTI, incidences of AEs, physical examination, vital signs and lab parameters	At randomization visit (baseline) and at 12 week (end of study)

Trial Locations

Locations (6): Bhakti Vedanta Hospital
🇮🇳
Thane, MAHARASHTRA, India
Bhatia General Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Brahma-Kumaris BSES M G Hospital
🇮🇳
(Suburban), MAHARASHTRA, India
Inamdar Hospital
🇮🇳
Pune, MAHARASHTRA, India
Muljibhai Patel Urological Hospital
🇮🇳
Kheda, GUJARAT, India
Rushabh Uro Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Bhakti Vedanta Hospital
🇮🇳Thane, MAHARASHTRA, India
Dr Siva Prasad Gourabathini
Principal investigator
918879614446
g.sivaprasad@yahoo.com