Health Condition 1: N308- Other cystitis
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria will be included in the study: 1. Adult female & male patients aged between more than or equal to 18 and less than or equal to 60 years A. With at least two of the following mild to moderate signs or symptoms using symptomatic assessment scale (Appendix 2): i. Dysuria/Burning micturition ii. Increased Urinary frequency iii. Urinary urgency iv. Suprapubic pain & B. Pus cell count more than or equal to 10 to less than or equal to 25 WBCs/HPF Note: To confirm eligibility, patients must have clinical symptoms accompanied by elevated pus cell levels. 2. Patients with at least three episodes of cystitis/year or two episodes of cystitis in the last six months. 3. Patients with signs & symptoms of recurrent Uncomplicated UTI which do not require antibiotic therapy at the time of screening as per Investigator discretion. 4. Patients willing to sign informed consent and follow the study procedure. 5 . Patients who have not participated in any similar clinical study in the last three months of screening. 6. A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: a. Has not undergone a hysterectomy or bilateral oophorectomy & salpingectomy or b. Has not attained menopause (Women not menstruating for atleast 12 consecutive months).
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Patients with signs or symptoms of systemic illness or chronic infection such as fever greater than 102 degree F, shaking chills, or other clinical manifestations suggestive of complicated UTI as per Investigator discretion. 2. Patients with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital, immunological or any other disorder that can interfere with the study conduct and outcome in the opinion of the Investigator. 3. Women in the postmenopausal phase (defined clinically or by history of amenorrhea more than or equal to 12 months) in whom the investigator determines that clinical symptoms are more consistent with a non-infectious or non-bacterial etiology will be excluded. 4. Patients who are undergoing treatment with antibiotics for the same or any other reason or who have taken antibiotic treatment within last 1 month. 5. Patients taking dietary, herbal supplements or any other medication within last 10 days for the treatment of recurrent UTI which may interfere with the study result in the opinion of Investigator. 6. Patients with history of neurogenic bladder, concomitant urogenitalinfection 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. 7. Male Participants with severe complicated UTI secondary to prostatitis, epididymitis, benign prostatic hyperplasia, urolithiasis along with systemic symptoms requiring antibiotics, hospitalization or other surgical treatments for comorbidities. 8. Patients 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 which may interfere with the study results in the opinion of investigation. 9. Patients with uncontrolled diabetes mellitus (defined as glycated hemoglobin [HbA1c] more than or equal to 9%) will be excluded from the study. (RBS level of more than 200mg per dl, confirmed by HBA1C more than or equal to 9%) 10. Pregnant as assessed by UPT & History of Amenorrhea or lactating women. 11. Any other conditions physical, psychological, or social that can interfere with the Patient s compliance to the study in the opinion of the Investigator. 12. Patients with known history of GI disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score more than 1 for any one of the 15 questions to be excluded). 13. Patients with known history of allergic response to any of the ingredients of the investigational product. 14. Known case of alcohol or any other substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints Reduction in overall symptoms of UTI at EOS as compared to baseline. Onset of relief from symptoms of UTI/Cystitis. Reduction in Pus cell (Pyuria) & Bacterial count at EOS as compared to baseline. Assessment in Overall Urine routine examination at EOS. Proportion of participants withdrawing from the study due to worsening of UTI/Cystitis. Improvement in quality of life at EOS as compared to baseline. Safety Endpoint Safety evaluation through Incidence of adverse events during the study period. Gastrointestinal tolerability during the study period.Timepoint: Day 1, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed