Use Of Beejpushti Rasa in treatment of low sperm count.

A proof of concept, interventional, single center, open label, single arm study to evaluate the safety and efficacy of beejpushti rasa in participants with oligospermia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041380

Enrollment

100

Registered

2022-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N461- Oligospermia Health Condition 2: N538- Other male sexual dysfunction

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male participants aged 22 to 40 years. 2.Participants having history of infertility since last 1 year and seeking management for the same. 3.Participants with history of regular sexual intercourse with sexually normal female partner. 4.Sperm count below 15 million/ml on two occasions separated by at least 1 week duration. 5.Body Mass Index lower than 35 kg/m2 6.Participants willing to give specimen of semen before and at the end of the study. 7.Participants willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1.History of Testicular mal descent, previous reproductive organ surgery, Sexually Transmitted Diseases, HIV/ AIDS, varicocele, hydrocele, hypertension. 2.Participants with a history of mumps, measles, small pox, chicken pox, tuberculosis. 3.Participants with history of Diabetes mellitus, Thyroid disorders, and any other major systemic disease, injury to genitalia or metabolic disorders. 4.Participants with history of psychiatric illness. 5.Participants giving history of addiction to drug, tobacco or alcohol. 6.Participants receiving or having received any infertility treatment for the past 1 month and any other treatment being received simultaneously that may influence the study. 7.Participation in another clinical trial or receipt of any investigational medicinal product in the past 3 months

Design outcomes

Primary

Measure	Time frame
To study the effect of Beejpushti Rasa on sperm count increase in participants with oligospermia after 90 days of treatment as compared to the baseline.Timepoint: Sperm count increase in participants after 90 days of treatment as compared to the baseline.	—

Secondary

Measure	Time frame
1.To study the effect of Beejpushti Rasa on sperm count and morphological characteristics of sperm i.e. normal forms, live forms, motility etc. after 90 days of treatment as compared to the baseline. 2.To study the effect of Beejpushti Rasa on serum testosterone levels after 90 days of treatment as compared to the baseline. 3.To assess the safety of Beejpushti Rasa with respect to haematological parameters like Complete Blood Count (CBC), Liver Function Test (LFT) [AST, ALT, S. Bilirubin], Renal Function Test (RFT) [BUN and S. Creatinine], Fasting Plasma Glucose (FPG) and Urine Routine and Microscopy after completion of 90 days of treatment Questionnaire based subjective evaluation of sexual parameters including sexual desire, erectile dysfunction and ejaculatory function, overall satisfaction and frequency of coitus after 45 days and 90 days of treatment as compared to the baseline.Timepoint: Baseline after 90 days of treatment as compared to the baseline.	—

Measure

Time frame

1.To study the effect of Beejpushti Rasa on sperm count and morphological characteristics of sperm i.e. normal forms, live forms, motility etc. after 90 days of treatment as compared to the baseline. 2.To study the effect of Beejpushti Rasa on serum testosterone levels after 90 days of treatment as compared to the baseline. 3.To assess the safety of Beejpushti Rasa with respect to haematological parameters like Complete Blood Count (CBC), Liver Function Test (LFT) [AST, ALT, S. Bilirubin], Renal Function Test (RFT) [BUN and S. Creatinine], Fasting Plasma Glucose (FPG) and Urine Routine and Microscopy after completion of 90 days of treatment Questionnaire based subjective evaluation of sexual parameters including sexual desire, erectile dysfunction and ejaculatory function, overall satisfaction and frequency of coitus after 45 days and 90 days of treatment as compared to the baseline.Timepoint: Baseline after 90 days of treatment as compared to the baseline.

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Countries

India

Contacts

Public ContactDr Reetu Sharma

National Institute of Ayurveda

drbks6@gmail.com9352311105

Outcome results