Clinical Study of Anti-Microbial Hand And Body Wash Gel

Comparative Clinical Anti-Microbial Efficacy Study of 0.3% w/v Octenidine Dihydrochloride Hand And Body Wash Gel - NA

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/03/018323

Enrollment

Registered

2019-03-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 0.3% w/v Octenidine dihydrochloride gel wash: 0.3% w/v Octenidine dihydrochloride gel wash for over 30 secs with hand rubbing on 0 day, 07 day and 14 day of 14 days clinical study Contr

Eligibility

Inclusion criteria

Inclusion criteria: 1) Normal healthy human volunteers should be included. 2) Subjects between the age above 18 to 65 years from both sex. 3) Patients willing to sign an informed written consent and comply with visit schedules. 4) Patients must be able to communicate effectively with study personnel. 5) Subjects should not have unbroken skin on either hands or feet.

Exclusion criteria

Exclusion criteria: 1) Patient with sign and symptoms of viral, bacterial or auto-immune skin infection. 2) Known positive status and known history for viral, bacterial or auto immune skin infections. 3) Broken,cracked or burnt skin on hands or feets. 4) Volunteers should not have any disease. Especially dermatological diseases should not be included. 5) Subjects on any other experimental treatment within 07 days of the first day of study drug or who have not recovered from the side effects of any such therapy. 6) Patient have history of hospitalized treatment before 07 days. 7) Patient taking any other then investigational drug in last 07 days.

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the antimicrobial effectiveness of a Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel Vs. propanol-2-ol (60%) and diluted dettol anti-septic solution (1:20) disinfectant solution when used for hygienic handwash purpose.Timepoint: Complete medical examination will be done by principal investigator on screening day along with blood test. Following parameters will be measured on initial(enrollment) day, 07 day and 14 day after screening of skin of hand and feet at each visit: CFU count of culture of micro-organisms before and after application of intervention/comparator agent Examination of hand and feet includes: General Appearance and skin condition of hand and feet	—

Measure

Time frame

To evaluate and compare the antimicrobial effectiveness of a Octenidine Dihydrochloride 0.3% Hand & Body Wash Gel Vs. propanol-2-ol (60%) and diluted dettol anti-septic solution (1:20) disinfectant solution when used for hygienic handwash purpose.Timepoint: Complete medical examination will be done by principal investigator on screening day along with blood test. Following parameters will be measured on initial(enrollment) day, 07 day and 14 day after screening of skin of hand and feet at each visit: CFU count of culture of micro-organisms before and after application of intervention/comparator agent Examination of hand and feet includes: General Appearance and skin condition of hand and feet

—

Secondary

Measure	Time frame
To observe any side effect and any serious adverse reactionTimepoint: Any adverse reaction or side effects shall be reported to principal investigator and sponsor immediately. During the Study follow-up visits and after one week of completion of 14 days study, subjects will be consulted for any adverse reaction or side effects is being observed.	—

Countries

India

Contacts

Public ContactDr Manish Rachchh

Accuprec Research Labs Pvt. Ltd.

sm_micro@accuprec.in9823660699

Outcome results