| CTRI Number |
CTRI/2021/03/032136 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The study to evaluate the efficacy and safety of DAPAD COMPLEX dietary supplement as an adjuvant therapy in treatment of uncomplicated acute urinary tract infections (UTI) |
|
Scientific Title of Study
|
A randomized double blind, two arms, parallel assignment, placebo controlled study to evaluate the efficacy and safety of DAPAD COMPLEX dietary supplement as an adjuvant therapy in treatment of uncomplicated acute urinary tract infections (UTI) |
| Trial Acronym |
none |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BIAG-CSP-046 version 2.0 dated 29June2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvashi P Bhatara |
| Designation |
Consultant - gyneacologist |
| Affiliation |
Rajalakshmi Hospital and Research Center |
| Address |
Rajalakshmi Hospital and Research center, 21/1, 3rd floor Laxmipura main Road, Vidyaranyapure Post
Bangalore
KARNATAKA
560097
India |
| Phone |
9448696741 |
| Fax |
|
| Email |
urvashibhatara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Divya Chandradhara |
| Designation |
CEO |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
#2/5, 3rd Floor Dahlia Building, 80ft Road, RMV 2nd Stage,
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Divya Chandradhara |
| Designation |
CEO |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
#2/5, 3rd Floor Dahlia Building, 80ft Road, RMV 2nd Stage,
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Giellepi S.p.A. HEALTH SCIENCE division,
via B. Cellini 37,
20851 Lissone (MB) Italy
|
|
|
Primary Sponsor
|
| Name |
Giellepi SpA |
| Address |
Health Science division,
via B. Cellini 37,
20851 Lissone (MB) Italy
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Suman |
Rajalakshmi Hospital and research center |
21/1, Laxmipura Main Road, 3d floor Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA |
9986046906
drsumanraj6@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajlakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAPAD Complex sachets, dietary supplement containing D-mannose, plant extracts and prebiotic fibres. |
2 sachets a day (Morning & Evening) dissolved in a glass of water (150 ml) and mix adequately for 5days |
| Comparator Agent |
Placebo |
2 sachets a day (Morning & Evening) dissolved in a glass of water (150 ml) and mix adequately for 5days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Adult Female Fertile age
Age ≥ 18 years to 45 years
Written informed consent
At least one of four key UTI symptoms that could be attributed to an uncomplicated UTI, and no alternative explanation (i.e. symptoms suggestive of STI or vulvo-vaginitis):
Dysuria
Urgency (including nocturia)
Frequency
Suprapubic tenderness
Urine culture positive for E.Coli ≥105 cfu/mL
|
|
| ExclusionCriteria |
| Details |
1. Male sex
2. Urine culture positive to uropathogens different from E. coli
3. Pregnancy or planned pregnancy
4. Concomitant antimicrobial therapy at the time of screening
5. Use of any antibiotics in the past 7 days
6. Use of dietary supplements (such as cranberry, probiotics, etc) during the month before recruitment
7. Known or suspected hypersensitivity or allergy to any ingredient of Investigational product
8. Active upper UTI (e.g. pyelonephritis, urosepsis: fever > 38.0, flank pain, chills)
9. Symptoms/signs suggestive of vaginitis or sexually transmitted infection
10. Indwelling catheter, nephrostomy, ureter stent or other foreign material
11. Otherwise complicated UTI:
• A history of anatomical or functional abnormalities of the urogenital tract:
• Congenital abnormalities
• Polycystic kidney disease
• Obstruction or stricture of renal pelvis, ureter or urethra
• Kidney stones
• Cystocele
• Cystic diverticulae
• Change of anatomical proportions (e.g. after ureter implantation)
• Chronic vesico-urethral reflux
• Neurogenic bladder
12. Severe chronic renal (creatinine clearance < 30 ml/min) or hepatic dysfunction
13. Diagnosis of diabetes
14. Immunosuppression:
• Untreated infection with the human immunodeficiency virus (HIV)
• Use of high-dose systemic corticosteroids or other immunosuppressive medication
• Chemotherapy
• Treatment with radiation
15. Critical illness requiring intensive care
16. Planned surgery within the next 6 weeks
17. Pelvic or gynecological surgery during the 6 months before recruitment
18. Inability to take oral drugs
19. Participation in another prospective clinical trial
20. Previous enrolment in the proposed study
21. Inability to understand or to follow the study protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical response at the end of treatment (day 6 ±2 days) and one month after the end of therapy. |
(day 6 ±2 days) and one month after the end of therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| bacteriologic response at the end of therapy |
day 6 ±2 days and one month after the end of therapy |
|
Target Sample Size
Modification(s)
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2021 |
| Date of Study Completion (India) |
23/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A urinary tract infection (UTI) is a collective term for infections that involve any part of the urinary tract. It is one of the most common infections in local primary care. The incidence of UTIs in adult males aged less than 50 years is low, with adult women being 30 times more likely than men to develop a UTI. Increasing rates of antibiotic resistance and high recurrence rates threaten to greatly enhance the burden that these common infections place on society. Ideally, alternative therapies will be established that will be recalcitrant to the development of resistance. Many promising approaches are being developed, from leveraging what we have learned about the basic biology of UTI pathogenesis to specifically target virulence pathways. DAPAD COMPLEX for the treatment of urinary tract infections and improves the urinary tract functions. This trial will help us to evaluate safety and efficacy DAPAD COMPLEX dietary supplement in treatment of uncomplicated acute urinary tract infections (UTI). This can be used as an alternative therapy for treatment of uncomplicated acute urinary tract infections.
|