Health Condition 1: N200- Calculus of kidney
Conditions
Interventions
Intervention1: 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, af
Sponsors
Meteoric Biopharmaceuticals Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 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
| Measure | Time frame |
|---|---|
| 1.Evaluate the safety of the test treatment in terms of abnormal changes in blood test parameters such as CBC, Serum Creatinine, SGPT, SGOT.Timepoint: On Day 01 (before administration) for baseline, and post-dosage on Day 14. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed