A clinical trial to compare the effect of a herbal formulation WH- 1 with Fluconazole, Tinidazole & FAS-3 kit in female patients with vaginitis.

A prospective, open labeled, randomised, comparative efficacy & safety trial of polyherbal formulation WH- 1 with Fluconazole, Tinidazole & FAS-3 kit in female patients with vaginitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000514

Enrollment

Registered

2010-08-11

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: WH-1: tid X 10 days Control Intervention1: fluconazole, tinidazole, FAS-3 kit: . Fluconazole 150 mg single dose 2. Tinidazole 1gm b.d ( total of two g

Eligibility

Inclusion criteria

Inclusion criteria: After getting the IERB approval. Married women in the age of 18 to 60 years. Patients/Subjects diagnosed to have vaginitis. Subjects proven to be eligible through clinical, biochemical examination. ? No clinical evidence of hepatic or renal impairment. ? Subjects who have given written informed consent. ? Female patients / subjects who have given consent for their partner to be included in trial

Exclusion criteria

Exclusion criteria: Pregnant & lactating women. Chronic disorder such as cardiac (hypertension uncontrolled, arrhythmia), diabetes and endocrine dysfunction (thyroid uncontrolled) as assessed through clinical examination / lab investigations. Women with multiple partners.? Subjects with h/o smoking, alcohol & drug dependence etc. History of Allergy to herbal medication. Participating in any other study within six weeks preceding day one of the study. ? Patients currently on medication such as Metronidazole & other antifungal drugs.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy and safety of polyherbal preparation WH-1 with Fluconazole, Tinidazole and FAS-3 kit for vaginitis.Timepoint: day 14	—

Secondary

Measure	Time frame
To evaluate the spectrum of activity of polyherbal formulation WH-1 against various organisms causing vaginitis. Timepoint: on day 14	—

Countries

India

Contacts

Public ContactDr. chanda kulkarni

MCI

drchandakulkarni@gmail.com080 : 22065045

Outcome results