| CTRI Number |
CTRI/2024/05/067236 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to determine the safety and efficacy of an oral probiotic supplementation in reducing the risk of kidney stone in adults with recurrent kidney stone colic or acute episode of colicky pain. |
|
Scientific Title of Study
|
A preliminary investigation of the safety and effectiveness of oral probiotics supplementation for reducing the risk of kidney stone in adults with recurrent kidney stone colic or acute episode of colicky pain: An open-label, single-arm, prospective, interventional, proof-of-science study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240020-MB Ver, 1.0 26 Apr 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hardik Yadav |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382 421, Gujarat, India.
Gandhinagar
GUJARAT
382421
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub- Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382 421, Gujarat, India.
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar – 382 421, Gujarat, India.
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Meteoric Biopharmaceuticals Pvt. Ltd. 9th Floor, Earth Arise,
Near YMCA Club, S.G Highway, Makarba,
Ahmedabad – 380 015, Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Meteoric Biopharmaceuticals Pvt. Ltd. |
| Address |
Meteoric Biopharmaceuticals Pvt. Ltd.
9th Floor, Earth Arise,
Near YMCA Club, S.G Highway, Makarba,
Ahmedabad – 380 015, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hardik Yadav |
Excel Orthopedic and Kidney Care Hospital |
Excel Orthopedic and Kidney Care Hospital
Centre Point, 419-421,
Near Savvy Swaraj, Gota
Ahmadabad
GUJARAT |
917948983895
consultant@novobliss.in |
| Dr Hardik Yadav |
NovoBliss Research Pvt. Limited |
NovoBliss Research Pvt. Ltd.
Office A 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar 382421,
Gujarat India
Gandhinagar
GUJARAT |
917948983895
consultant@novobliss.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MetProrenes (Slow-Release Capsule) |
Dosage Form: Slow Release Capsule
Frequency: Twice a day
Route of Administration: Oral
Mode of Usage: Take one slow-release capsule twice a day, after meal. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.The subject is an adult aged between 18 to 55 years old.
2.The subject has a history of recurrent kidney stone colic or acute episode of colicky pain on clinical examination by Physician.
3.The subject is willing to provide written informed consent and comply with study procedures, including overnight stay for 24 hours at the study centre during both visits.
4.The subject is willing to abide by the study protocol and restrictions, including abstaining from using any other oral or topical treatments for kidney stone colic during the study period.
5.The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
6.If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
a.Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
b.Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.
|
|
| ExclusionCriteria |
| Details |
1 Subject has a history of severe renal impairment or chronic kidney disease.
2 Subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
3 Subject has presence of significant medical or psychiatric conditions that may interfere with study participation or interpretation of results.
4 Subject has a history of substance abuse or dependence.
5 Subject has severe systemic complications of viral infections, cardiovascular disorders, neurological disorders, renal disorders, or autoimmune disorders.
6 Subject has participated in clinical studies or received any investigational agent in the previous 30 days.
7 Subject has any condition that, in the judgement of investigator, would compromise the safety of subject or study integrity. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluate the effect of the test treatment in term of change in the colicky pain determined using the VAS scoring.
2.Evaluate the effect of the test treatment in terms of changes in urinalysis parameters such as Urine Calcium, Sodium, Oxalate, pH, and R/M, after 24h-urine collection
|
1. Scoring on Day 01 (before administration) for baseline, and post-dosage on Day 14.
2. On Day 01 (before administration) for baseline, and post-dosage on Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Evaluate the safety of the test treatment in terms of abnormal changes in blood test parameters such as CBC, Serum Creatinine, SGPT, SGOT. |
On Day 01 (before administration) for baseline, and post-dosage on Day 14. |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Reducing the Risk of Kidney Stone in Adults with Recurrent Kidney Stone Colic or Acute Episode of Colicky Pain: An Open-Label, Single-Arm, Prospective, Interventional, Proof-of-Science Study. Maximum 12 subjects will be enrolled to complete the study. Duration will be of approximately 14 days which includes 2 visits. Visit 01 [Day 01]: Screening, baseline evaluations, enrolment and treatment dispensing. Visit 02 [Day 14]: Treatment End, Final Evaluations.
|