| CTRI Number |
CTRI/2018/07/014706 [Registered on: 02/07/2018] Trial Registered Prospectively |
| Last Modified On: |
10/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY TO EVALUATE THE EFFECT AND SAFETY OF AN AYURVEDIC DRUG (URAL CAPSULE) IN RENAL STONES |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN AYURVEDIC FORMULATION - URAL CAPSULE IN THE TREATMENT OF UROLITHIASIS |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Joravar Singh Gate, Amer Road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Joravar Singh Gate, Amer Road, Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Shalya Tantra, National Institute of Ayurveda, Joravar Singh Gate, Amer Road, Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
|
Source of Monetary or Material Support
|
| M/s Vasu Research Centre (A Division of Vasu Healthcare Pvt. Ltd.) 967/4, GIDC, Makarpura, Vadodara - 390010 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Joravar Singh Gate, Amer Road, Jaipur- 302002 |
| Type of Sponsor |
Other [Central Government Institute for UG, PG Education & Research in Ayurveda Under Ministry of AYUSH] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Vasu Research Centre |
M/s Vasu Research Centre (A Division of Vasu Healthcare Pvt. Ltd.) 967/4, GIDC, Makarpura, Vadodara - 390010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Kumar |
Campus Hospital, National Institue of Ayurveda |
OPD No. 4 & 32, Department of Shalya Tantra,
Jaipur
RAJASTHAN |
9649180572
ashok_hp1976@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from Stones in Kidney, Ureters and Urinary Bladder , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Ural Capsule |
Each hard gelatin capsule contains
Extracts of -
Boerhaavia diffusa (Punarnava) Root 56.25mg
Tribulus terrestris (Gokshur) Fruit 50 mg
Berginia ligulata (Pashanbhed) Root 50 mg
Crataeva nurvala (Varun) Bark 45 mg
Dolichos biflorus (Kulathi) Seed 45 mg
Achyranthes aspera (Apamarg) Panchanga 15 mg
Powders of
Hajrool Yahood Bhasma Formulation 80 mg
Chandraprabha Vati Formulation 75 mg
Shuddha Shilajit Mineral 50 mg
Kasis Bhasma Formulation 25 mg
Excipient --- Q.S.
Total duration of the study will be 3 months.
2 capsules twice daily will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients of both sexes in the age group of 18 to 60 years will be selected for the present study.
(2) Patients who willing to sign written consent and comply with the study procedure.
(3) Patients having stone in kidney / ureter / bladder (KUB) greater than 5 mm but < 12 mm in size
|
|
| ExclusionCriteria |
| Details |
(1) Patients below 18 years and above 60 years
(2) Patients having uretero-hydronephrosis, diabetes, ulcer disease, history of hypersensitivity to herbal formulation
(3) Patients suffering from serious systemic disorders
(4) Patients with severe complication and requiring immediate surgery
(5) Pregnant or lactating women
(6) Patients who are unwilling to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of trial drug on urolithiasis |
3 months clinical trial and 2 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the trial drug |
During treatment and in follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Evaluation of Acute Toxicity and Anti-Urolithiatic Activity of Ural Capsule - , Hardik Soni.et al./ International Journal of Phytopharmacology,5(1),2014,15-20 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stone formation in kidney is one of the oldest and the most
widespread medical afflictions known to humans. It is a most common urinary
tract problem all over the world, having prevalence rate of 2.3%. Patients
between ages of 20-50 years have peak incidence of stone formation. In India,
6-8% population suffers from kidney stone. Ural Capsule is a patent &
proprietary Ayurvedic formulation, recommended for treatment of urolithiasis.
Previous experimental data has confirmed its safety and efficacy. Hence the
present study is to be initiated to evaluate its clinical safety and efficacy.
Open labelled, interventional clinical trial protocol has been designed to
evaluate efficacy and safety of Ural Capsule in treatment of urolithiasis.
Inclusion and exclusion criteria have been mentioned in protocol for selection
of patients. All selected patients will be treated with Ural Capsule for 3
months (12 Weeks). For the assessment of efficacy different clinical parameters
such as subjective parameters, Blood urea, Serum uric acid, Serum creatinine,
X-ray (KUB) & Ultrasonography (KUB) will be considered. Routine
haematological parameters, routine urine analysis and routine stool analysis
will be done to evaluate safety of the drug. Follow-up visit will be scheduled at
1 month interval after compilation of treatment up to 2 months. Appropriate
statistic will be applied to find out statistical significance level.
Key
Words : Ashmari, Urolithiasis, Kidney stones, Ural
capsule. |