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Evaluating efficacy and safety of Unani drug in Sayal ?n al-Ra?im (Leucorrhoea)

Phase 2
Conditions
Health Condition 1: N949- Unspecified condition associated with female genital organs and menstrual cycle
Registration Number
CTRI/2023/10/058205
Lead Sponsor
ational Research Institute Of Unani Medicine For Skin Disorders
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

i) Female patients in the age group of 13-45 years

ii) Patients of Sayal ?n al-Ra?im (Leucorrhoea) having the following symptoms:

a) Excessive white or creamy vaginal discharge evident from persistent vulvar moistness or staining of the undergarments (brownish-yellow stain on drying) or need to wear a vulvar pad, with or without any of the following associated symptoms:

b) Waja‘ al-Kh ??ira (Low Backache)

c) ?u’f-i-‘Am (General Weakness)

d) Non-infective Leucorrhoea

Exclusion Criteria

i) Age below 13 years and above 45 years

ii) Patients with Pelvic Inflammatory Disease (PID), Infective leucorrhea

iii) Positive History of Venereal Disease/ Sexually Transmitted Disease (Syphilis, Gonorrhoea)

iv) Patients using oral contraceptive pills (OCPs), intrauterine contraceptive device (IUCD), hormone therapy, and any long-term medications

v) Significant Pulmonary/Cardiovascular/Hepato-Renal Dysfunction

vi) Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies

vii) Post-delivery or post-abortion period of <6 weeks

viii) Pregnant and lactating women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction in Discharge per vaginum from baseline after treatment of 6 weeks <br/ ><br>Timepoint: 42 Days
Secondary Outcome Measures
NameTimeMethod
i) Relief in Low Backache <br/ ><br>ii) Improvement in symptoms of generalized weakness <br/ ><br>iii) Systemic Safety assessmentTimepoint: 42 Days
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