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Clinical efficacy of kantaka panchamoola in Shukra Dushti

Phase 2
Conditions
Health Condition 1: N461- OligospermiaHealth Condition 2: N468- Other male infertility
Registration Number
CTRI/2022/03/041228
Lead Sponsor
Ayurvedic and Unani Tibbia College and Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
64
Inclusion Criteria

a) Male Patients between the age group of 21-50 years of age.

b) Willing and able to participate in the study for 90 days.

c) Patients suffering from semen disorders over the past 6 months or more.

d) Patients with History of Infertility for the past 3 years.

f) Patients with lack of libido / sexual desire/ Impotence/ Erectile Dysfunction.

g) Patients with Difficulty in ejaculation of semen.

h) Patients ejaculating little quantity of semen after painful coitus.

Exclusion Criteria

a) Men with a total sperm concentration of < 5â??million/mL

b) Patients having a history of congenital deformity in genitals.

c) Patients with evidence of Malignancy.

d) Patients having any type of surgery of genitals.

e) Known case of serious hepatic, cardiac or kidney diseases.

f) Patients having history of Chronic Fever.

g) Patient having any sexual transmitted diseases.

h) Patients on prolonged medication with corticosteroids, antidepressants,

anticholinergics, immunosuppressant, etc. or any other drugs that may have an

influence on the outcome of the study.

i) Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mm of

Hg) despite of antihypertensive agents.

j) Hypersensitivity to any of the trial drugs or their ingredients.

k) Patients who have completed participation in any other clinical trial drugs or their

ingredients.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The Expected Primary End point is improvement in the semen parameters. <br/ ><br>levels from baseline (Day 1) after 90 days of therapyTimepoint: 3 months
Secondary Outcome Measures
NameTimeMethod
The Expected secondary outcome is the safety and efficacy of the therapy under investigation. <br/ ><br>Safety will be assessed based on the adverse events recorded during the studyTimepoint: 3 months
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