Department of Urology, 2nd Floor, Dr. Siva Prasad’ OPD, Bhakti Vedanta Hospital, Srishti Complex, Bhakti Vedanta Swami Marg, Mira Road (East), Dist- Thane- 401107, Maharashtra, India. Thane MAHARASHTRA
918879614446
g.sivaprasad@yahoo.com
Dr Pratit Samdani
Bhatia General Hospital
Room NO. 5, Ground Floor,G1 Department, Bhatia General Hospital, Zoroastrian Colony, Tardeo Road , Grant Road (W),Mumbai-400007, Maharashtra, India Mumbai MAHARASHTRA
912266660000 912266660566 drpratit@gmail.com
Dr Nilesh Rangnekar
Brahma-Kumaris BSES M G Hospital
BSES Municipal General Hospital,Department of Urology, Clinic No. 01, 2nd floor, Opp. Merwans Bakery, S.V. Road, Andheri (W), Mumbai-400058, India. Mumbai (Suburban) MAHARASHTRA
912266487570 912226114500 drneil4ever@yahoo.com
Dr Rajendra Shimpi
Inamdar Hospital
Research Room No. 1,Floor Basement 2, Department of Urology,Inamdar Multispeciality Hospital, Hospital Building, S.NO.15, Fatima Nagar,Pune-411040, Maharashtra, IndiaHospital Building, S.NO.15, Fatima Nagar,Pune-411040, Maharashtra, India Pune MAHARASHTRA
0206137494 02026055094 rajendrakshimpi@gmail.com
Dr Ravindra B Sabnis
Muljibhai Patel Urological Hospital
Department of Urology, OPD number 10, 11 & 12, First Floor, Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad- 387001, Gujarat, India. Kheda GUJARAT
919426422002
rbsabnis@gmail.com
Dr Shrenik Shah
Rushabh Uro Hospital
2nd Floor, Heritage Plaza, Opp. Gurukul Tower, Drive in Road, Ahmedabad – 380052, Gujarat, India. Ahmadabad GUJARAT
IBHB tablets (300 mg, one tablet, twice a day orally) for 12 weeks
Comparator Agent
Placebo tablets
Placebo tablets (300 mg, one tablet, twice a day orally) for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) 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
ExclusionCriteria
Details
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 investigator’s opinion may threaten the subject’s ability to complete the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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)
Target Sample Size
Total Sample Size="80" Sample Size from India="80" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.