A Comparative Clinical study to see the effect of some Ayurvedic formulation in patients of itching in vulva

Phase 2

Not yet recruiting

• Conditions: Other specified inflammation of vagina and vulva. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH योनिरोगः/योनि-वà¥à¤¯à¤¾à¤ªà¤¦à¤ƒ,

• Registration Number: CTRI/2021/03/032120
• Lead Sponsor: State Ayurvedic College and Hospital lucknow

Brief Summary

Type of study-Randomized comparative parallel open clinical trial, to evaluate and compare the effect of Guduchidantydi Vati and Guduchidantyadi Malahar in Acharana yonivyapada( pruritus vulvae). 40 patients  in the age group  of 18 to 45 years will be registered randomly from OPD and IPD of PG department of Prasuti tanta and Stri roga State Ayurvedic College and Hospital Lucknow after taking permission from Institutional Ethics committee and consent from the patient.

Patients will be allocated in group A and Group B of 20 patients each.

Group A-Guduchidantyadi Vati  will be administrated orally for 21 days

Group B- Guduchidantyadi Malahar local application for 21 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Patients willing to participate in trial Adult Female who are in age group of 18-45 years Only married patient Patients having pruritus vulvae as a cardinal symptom with or without vaginal discharge.

Exclusion Criteria

• Patients below 18 years and above 45 years Patients unwilling too participate in the trial Patients after menopause.
• Patients who are willing to conceive.
• Patients of uterine prolapse and Ca-cervix.
• Patients on oral contraceptives or using intra uterine contraceptive device.
• Patients with diabetes mellitus, tuberculosis, severe hypertension, jaundice.
• Patients with chronic cervicitis, fibroid and malignancy.
• VDRL, HIV, HBsAg positive patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of oral administration of Guduchidantyadi Vati and Guduchidantyadi Malahar in Pruritus vulvae	Trial will be conducted for 1 month ( 21 days with medicine and 7 days without medicine) .Patient will be followed once a week during treatment and 7 days after the treatment is completed.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of trial drug on subjective parameters white discharge p/v, malodor, vulvar pain , coital frequency , dyspareunia , burning micturition & inflammation in vulva	1 month

Trial Locations

Locations (1)

State Ayurvedic College and Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Ekta Dubey

Principal investigator

8573801803

ektadubey.0110@gmail.com