Clinical Study on DaburAyurvedic formulation for its effect on Kidney stones

Phase 2/3

Completed

Conditions: Calculus of kidney,

Registration Number: CTRI/2014/08/004888

Lead Sponsor: Dabur India Limited

Brief Summary: This study will be Multi-center, Randomized, Open Labeled, Prospective, Comparative Clinical Study to evaluate efficacy and safety of Dabur Ayurvedic formulation, in comparison with Marketed Ayurvedic Formulation in Urolithiasis. Patients having renal stone(s)in the age group of 18 - 65 years. Subjects will be advised to take 2 tablets of Dabur Ayurvedic Formulation or Marketed Ayurvedic Formulation Tablet thrice daily orally after food with water for 90 days. Total completers for the study is planned to be 100 subjects. Treatment period will be of 90 days with total of 7 visits including screening visit.

Dabur Ayurvedic formulation is a poly herbal formulation containing Varuna extract (*Crataeva nurvala*), Rakta Punarnava extract (*Boerhaavia diffusa*), Gokshura extract (*Tribulus terrestris*), Guduchi extract (*Tinospora cordifolia*), Daruharidra extract (*Berberis aristata*), Pashanbheda (*Bergenia ligulata*), Apamarga (*Achyranthes aspera*), Shwet Parpati (Classical Ayurvedic Formulation), Shilajatu (Shuddha), Hajaul Yahood Bhasma.

Marketed Ayurvedic Formulation is a polyherbal formulation containing Pashanbhed (*Bergenia ligulata*), Punernava (*Boerhaavia diffusa*), Palash Pushap (*Butea monosperma*), Hajrul Yahood Bhasam, Swait Parpati (Classical Ay. Preparation), Varun Ghan (*Crataeva nurvala*), Sahdevi (*Vernonia cinerea*), Appamarg Panchang (*Achyranthes aspera*), Gokhru (*Tribulus terrestris*), Sudh Shilajeet (Purified Asphaltum), Lajaloo Mool (Mimosa pudica), Yavakshar (ash of *Hordeum vulgare*), Pashanbhed (*Bergenia ligulata*), Appamarg (*Achyranthes aspera*), Lajaloo Mool (*Mimosa pudica*), Gokhru (*Tribulus terristris*), Kulthi (*Dolichos biflorus*) and Maddarmool (*Calotropis procera*)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Males and females of age 18-65 years (both inclusive) 2.
Renal stone diagnosed by X-ray KUB and USG abdomen and Pelvis 3.
Patients having renal stone(s) greater than 05 mm and less than 12 mm in size 4.
Patients with or without symptoms such as hematuria, dysuria, pain in abdomen, and burning micturition 5.
Patient not taking any other lithotriptic agent 6.
Patient able and willing to give written informed consent and comply with the requirements of the study protocol 7.
Females of reproductive potential willing to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation.

Exclusion Criteria

Patients having acute renal colic 2.
Patients with stone in lower calyx.
Patients with moderate to severe uretero-hydronephrosis 4.
Complicated cases of Renal Calculi requiring surgical intervention 5.
Chronic Renal Failure 6.
Patients clinically significant urinary tract infections 7.
Patients with known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI) 8.
Patients with any other known urogenital disorders 9.
Patients on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 15 days 10.
Patients participated in another clinical drug study within 3 months before recruitment 11.
Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation 12.
Pregnant and breast feeding women 13.
Patients with clinically significant abnormal laboratory findings.
Subjects who refuse to sign the informed consent document 15.
Chronic Alcoholics 16.
Immunologically compromised individuals.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes:	subjects are assessed for reduction in stone size and number of stone at last visit in comparison with base line but Subject will be called to the hospital for follow up visits on day 15 \| (Visit I), day 30 (Visit II), day 45 (Visit III), day 60 (Visit IV), day 75 \| (Visit V)day 90
1. Reduction in stone(s) size	subjects are assessed for reduction in stone size and number of stone at last visit in comparison with base line but Subject will be called to the hospital for follow up visits on day 15 \| (Visit I), day 30 (Visit II), day 45 (Visit III), day 60 (Visit IV), day 75 \| (Visit V)day 90
2. Reduction in number of stones	subjects are assessed for reduction in stone size and number of stone at last visit in comparison with base line but Subject will be called to the hospital for follow up visits on day 15 \| (Visit I), day 30 (Visit II), day 45 (Visit III), day 60 (Visit IV), day 75 \| (Visit V)day 90

Secondary Outcome Measures

Name	Time	Method
Assessment of number of patients with complete expulsion of stone(s), duration of expulsion of calculi, use of NSAIDs/ Anti-spasmodic drugs as rescue medicines,	overall Improvement in clinical symptoms: Pain in abdomen, Hematuria, Burning micturition, Pain during micturition, Pain Episodes, Frequency of micturition drug safety by assessing ( Adverse drug reaction & Clinically significant Laboratory abnormalities)

Trial Locations

Locations (3): ShalyaTantra Dept. Govt Ayurved College & Hospital
🇮🇳
Nanded, MAHARASHTRA, India
ShalyaTantra Dept. Sumatibhai Shah Ayurved Mahavidyalaya
🇮🇳
Pune, MAHARASHTRA, India
SHREE GURUDEOAYURVED COLLEGE
🇮🇳
Amravati, MAHARASHTRA, India
ShalyaTantra Dept. Govt Ayurved College & Hospital
🇮🇳Nanded, MAHARASHTRA, India
Dr Vijay Ukhalkar
Principal investigator
09422171987
ukhalkarvp@yahoo.com