| CTRI Number |
CTRI/2014/08/004888 [Registered on: 19/08/2014] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study on Dabur
Ayurvedic formulation for its effect on Kidney stones |
|
Scientific Title of Study
|
A Randomized, Open Labeled, Multi-center, Prospective,
Comparative Clinical Study to evaluate efficacy and safety of Dabur Ayurvedic formulation Stondab, in comparison with marketed Ayurvedic Formulation in Urolithiasis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| STON/URO/01/2014, Version 1.0, 19th June 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamalakar Vasant Gajare |
| Designation |
Principal Investigator |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
ShalyaTantra Dept.
Sumatibhai Shah Ayurved Mahavidyalaya,
Malwadi, Hadapsar,
Pune
MAHARASHTRA
411028
India |
| Phone |
09850123482 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head-Medical Affairs & Clinical Reserach |
| Affiliation |
Dabur India Limited |
| Address |
Dabur Research & Development Center, Dabur India Ltd, Plot no. 22, Site IV, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
120-3378614 |
| Fax |
120-4552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education & Research |
| Address |
Target Institute of Medical Education & Research, 205 B Wing, Blue Diamond Society, Nayagoan Dahisar (West)Mumbai
Mumbai
MAHARASHTRA
400068
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research & Deveolpment Center, Dabur India Limited, Plot No. 22, Site IV, Sahibabad, Ghaziabad, UP, 201010 |
| Type of Sponsor |
Other [Healthcare & FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Ukhalkar |
ShalyaTantra Dept. Govt Ayurved College & Hospital |
ShalyaTantra Dept.
Govt Ayurved College & Hospital
Nanded, Maharashtra 431601
Nanded
MAHARASHTRA |
09422171987
ukhalkarvp@yahoo.com |
| Dr Kamalakar Vasant Gajare |
ShalyaTantra Dept. Sumatibhai Shah Ayurved Mahavidyalaya |
ShalyaTantra Dept.
Sumatibhai Shah Ayurved Mahavidyalaya,
Malwadi, Hadapsar,
Pune-411 028
Maharashtra State, India
Pune
MAHARASHTRA |
09850123482
drgajarekv@gmail.com |
| Dr Podhade Suresh S |
SHREE GURUDEOAYURVED COLLEGE |
SHREE GURUDEOAYURVED COLLEGE,
GURUKUNJ, DIST. AMRAVATI,
MAHARASHTRA, INDIA
Amravati
MAHARASHTRA |
09850036968
suresh_podhade@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ayurved Mahavidyalaya Nashik |
Approved |
| Govt Ayurved College & Hospital Nanded |
Approved |
| Shri Gurudeo Ayurveda College |
Approved |
| Sumatibhai Shah Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Ayurvedic Formulation |
The product is recommended for use in Mutrasharmi (Urinary stone) and other urinary
tract disorders. The current study is planned for evaluating the effect of the drug on urinary stones.The product is developed Dabur India Ltd.
Dabur Ayurvedic Formulation have been tested for its effectiveness and safety in the preclinical studies.
Now to substantiate the same in human beings, the clinical study is planned to evaluate the efficacy and safety of the product in subjects suffering from urollithiasis.
Two Tablets thrice daily orally after meals with water for 90 days |
| Comparator Agent |
Marketed Ayurvedic Formulation |
Marketed Ayurvedic Formulation is a polyherbal formulation, which is effective in the treatment of urinary calculi (kidney stone) and urinary tract infections.
Two Tablets thrice daily orally after meals with water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 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 |
|
| ExclusionCriteria |
| Details |
1. Patients having acute renal colic
2. Patients with stone in lower calyx.
3. 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.
14. Subjects who refuse to sign the informed consent document
15. Chronic Alcoholics
16. Immunologically compromised individuals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
1. Reduction in stone(s) size
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
|
| Outcome |
TimePoints |
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) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Result s of the study of this clinical Trial may be used for publishing scientific papers and data. All the data generated on the trial will be exclusive property of sponsor; and no publication can be done without sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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) |