| CTRI Number |
CTRI/2012/01/002350 [Registered on: 18/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
18/01/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cystone in kidney stones |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy and safety of two Cystone formulations in patients suffering from Urolithiasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/023/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narasimhaswamy M S |
| Designation |
Professor |
| Affiliation |
Mandya Institute of Medical Sciences, mandya. |
| Address |
Department of Surgery,
Mandya Institute of Medical Sciences,
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
08232-231001 |
| Fax |
08232-231001 |
| Email |
drnarasimhaswamymandya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narasimhaswamy M S |
| Designation |
Professor |
| Affiliation |
Mandya Institute of Medical Sciences, mandya. |
| Address |
Department of Surgery,
Mandya Institute of Medical Sciences,
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
08232-231001 |
| Fax |
08232-231001 |
| Email |
drnarasimhaswamymandya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narasimhaswamy M S |
| Designation |
Professor |
| Affiliation |
Mandya Institute of Medical Sciences, mandya. |
| Address |
Department of Surgery,
Mandya Institute of Medical Sciences,
Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
08232-231001 |
| Fax |
08232-231001 |
| Email |
drnarasimhaswamymandya@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug company |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug |
| Address |
The Himalaya Drug Company
Research and Development, Makali,
Bangalore -562 123
Tel: 08022169999
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narasimhaswamy M S |
Department of Surgery |
Department of Surgery,
Mandya Institute of Medical Sciences,
Mandya-571401
Mandya
KARNATAKA |
08232-231001
08232-231001
drnarasimhaswamymandya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,MIMS,Mandya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cystone extract route tablet |
Dose-1 tablet twice daily
Duration - 3 months
Route - oral
frequency - twice daily |
| Comparator Agent |
Cystone tablet |
Dose-2 tablet twice daily Duration - 3 months
Route - oral
frequency - twice daily |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Subject with Urolithiasis as disgnosed by clinically as well as ultrasonographically with calculi measuring more than 5 mm.
• Hematologic and Biochemical parameters within normal limits.
• Willing to sign inform consent document
|
|
| ExclusionCriteria |
| Details |
• Those with serious cardiovascular, cerebrovascular, respiratory, liver or renal disease or any other disorder.
• The subjects not to have used any drugs, for at least 1 week prior to the study.
• Subjects with a strong history of food or drug allergy of any kind.
• Subjects not to have been on weight reducing diets within 3 months prior to the start of the study.
• No other drugs (including aspirin) to be ingested during the course of the study.
• Patients unwilling to provide informed consent or abide by the requirements of the study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptomatic relief from clinical symptoms of urolithiasis and reduction in the stone size by ultrasonography |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety profile of Cystone Extract route tablet in Urolithiasis and overall compliance to the drug treatment.
|
At monthly intervals for the period of 3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/10/2011 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Publication rights with the sponsor |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Each Cystone Extract Route Tablet contains following herbs:
Gokshura, Punarnava, Pasanabheda, Kulattha and Varuna.
Each Cystone tablet
contains following herbs:
Shilapushpa, Pasanabheda, Manjishtha, Nagaramusta, Apamarga, Gojiha, Sahadevi, Hajrul yahood bhasma and Shilajeet (Purified).
The subjects presenting with symptoms of Urolithiasis like colicky pain, hematuria, dysuria, retention of urine, decrease in frequency of urination and other symptoms of Urolithiasis will be screened by the investigator.The subjects will be randomly assigned to either investigational product group or comparator group and will be instructed to take Cystone Extract route Tablet or Cystone tablet twice daily for 3 months. Subject will undergo general physical examination, systemic examination and abdominal examination specifically for renal stones on all the visits. During baseline and end of study, urine routine, ultrasonography abdomen and pelvis will be performed. Assessment will be done, at each visit at the end of 1 month, 2 month and 3 month. |