Health Condition 1: N300- Acute cystitis Health Condition 2: B998- Other infectious disease
Conditions
Interventions
Intervention1: HDCD-092330: 1 tablet twice daily orally after food for 28 days
(2 tablets twice daily to be titrated from Day14 to Day 28 in non-responders).
Control Intervention1: Placebo: 1 tablet
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult female & male between18 to 60 years. A.With at least two of the following mild to moderate signs or symptoms of Dysuria/Burning micturition, Increased Urinary frequency, Urinary urgency, Suprapubic pain B. Along with Bacteriuria greater than 10,000 CFU/ml. 2. Male subjects with signs & symptoms of cystitis which do not require antibiotic therapy 3. Can signed informed consent and willing to participate and follow the study procedures 4. No concomitant participation in any other clinical trial since last 3 months 5. Women of child-bearing potential must agree to use adequate contraception during study period
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital, immunological or any other disorder as assessed by medical history 2. Subjects with signs or symptoms of fever greater than 102 degree fahrenheit, shaking chills, or other clinical manifestations suggestive of Complicated Cystitis as per Investigator discretion. 3. Subjects who are undergoing treatment with Antibiotics for the same or any other reason or within last 1 month. 4. Subjects taking dietary, herbal supplements or any other medication within last 10 days for the treatment of cystitis . 5. Subjects with history of neurogenic bladder, concomitant urogenital infection such as urethritis, vaginitis (for females), pyelonephritis, benign or malignant tumors or any other pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications 6. Male subjects with severe complicated cystitis secondary to prostatitis, epididymitis, benign prostatic hyperplasia, urolithiasis along with systemic symptoms requiring antibiotics, hospitalization or other surgical treatments for comorbidities. 7. Subjects diagnosed with renal insufficiency (renal failure, bilateral obstruction, or solitary kidney), Arterial aneurysm in vicinity of stones, Anatomical obstruction distal to stone, Kidney tumors, chronic kidney disease, sepsis, chronic infection or any other renal disease 8. Subjects with Uncontrolled Diabetes with HbA1c values greater than 9% in last 3 months. 9. Pregnant and lactating women. 10. Any other conditions physical, psychological, or social that can interfere with the subject s compliance to the study in the opinion of the Investigator. 11. Subjects with known history of allergy to the study drug or any of its ingredients. 12. Known case of alcohol or any other substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in microbiological response-Percentage of subjects with non-significant bacteriuria (less than103cfu/ml) Improvement in clinical response -Reduction in overall symptoms of cystitis Timepoint: Visit 1: Screening (-10days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 14 3 days Visit 4: Day 28 3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assess the adverse events observed or reported during the study period with ovrall compliance of the subject to the study intervention. 2.The evaluation of Quality of Life Quality using QOL scale 3. A proportion of subjects withdrawing from the study due to worsening of symptoms.Timepoint: Visit 1: Screening (-10days to Day 0) Visit 2: Baseline/ Day 1 Visit 3: Day 14 3 days Visit 4: EOS/Day 28 3 days | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed