CLINICAL RESEARCH OF A SIDDHA MEDICINE VEERIYA VIRUTHI CHOORANAM IN THE TREATMENT OF AAN MALADU(MALE INFERTILITY)
- Conditions
- AAN MALADU (MALE INFERTILITY)
- Registration Number
- CTRI/2014/01/004278
- Lead Sponsor
- AYOTHIDOSS PANDITHAR HOSPITAL
- Brief Summary
It is a single, non-randomized, open-label trial to determine the efficacy and safety of VEERIYA VIRUTHI CHOORANAM (Prepared with eleven herbal constitutents in equal proportion) in patients with Aan maladu (Male infertility).In this trial 40 male infertility patients will be recruited and the trial drug will be administered 8 gms twice a day along with milk for a period of 90 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Male
- Target Recruitment
- 40
- 1.Male infertile 2.Age 21- 45 year 3.Maritial status.
- more than 1 year 4.Sperm count ≤ 40 million / ejaculation 5.Motility less than ≤ 50 % 6.Patient is willing to sign the informed consent stating that he will continuously stick to the treatment during 48days but can opt out of the trial of his own conscious discretion. 7.Patients who are willing to give specimen of blood , urine and semen before and after treatment.
1.Azoospermia 2.Hydrocele 3.Diabetes mellitus 4.Hypertension 5.Endocrine disorders 6.Caridiac diseases 7.VDRL & STD 8.Inguinal Hernia 9.Renal diseases 10.Varicose veins.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome is mainly assessed by increase in the sperm count and motility % PRE STUDY SCREENING AND AFTER TREATMENT
- Secondary Outcome Measures
Name Time Method CLINICAL ASSESSMENT PRE STUDY SCREENING AND AFTER TREATMENT
Trial Locations
- Locations (1)
AYOTHIDOSS PANDITHAR HOSPITAL
🇮🇳Kancheepuram, TAMIL NADU, India
AYOTHIDOSS PANDITHAR HOSPITAL🇮🇳Kancheepuram, TAMIL NADU, IndiaDR V VIJAYAKUMARPrincipal investigator9443017837vasy4777@yahoo.com