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Safety & Efficacy assessment of new Ayurvedic antimicrobial vaginal tablet for the treatment of leucorrhea through clinical trials.

Estimation of the therapeutic efficacy of a novel Ayurvedic Vaginal tablet in treating excessive abnormal vaginal discharge during Phase II clinical trials

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018852
Enrollment
210
Registered
2019-04-30
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

Health Condition 1: N761- Subacute and chronic vaginitis

Interventions

Intervention1: Ayurvedic mucoadhesive vaginal tablet combination of equal amounts of dried parts of the stem bark of Udumber Ficus glomerata Roxb.andLodhra Symplocos racemosa Roxb: One Ayurvedic nove

Sponsors

Institute of Post Graduate Ayurvedic Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Continuous per vaginal excessive abnormal white discharge except ovulation period 2 Itching around the external genital parts 3 Pain in the back region 4 Painful intercourse

Exclusion criteria

Exclusion criteria: 1 Pregnancy 2 History of significant per vaginal bleeding 3 prolapsed of uterus 4 Malignancy in the internal genital parts 5 Allergy to known constituents 6 Severely ill patients

Design outcomes

Primary

MeasureTime frame
Reduction in excessive abnormal vaginal discharge and associated symptoms, improvement in genital health condition and well beings.Timepoint: The final outcome of each participant will be evaluated after 15 days of treatment,i.e at the end of her study period.

Secondary

MeasureTime frame
The primary outcome will be justified on the basis of vaginal fluid study, microbiological study, Routine haematological investigation,hormone FSH, LH, TSH analysis and also urine in this studyTimepoint: Day 1 Day 15 Pre treatment and post treatment analysis

Countries

India

Contacts

Public ContactDr Mradu Gupta

Institute of Post Graduate Ayurvedic Education and Research

mradu_gupta@hotmail.com9433665125

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026