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Clinical Trials/CTRI/2024/04/065757
CTRI/2024/04/065757Not yet recruitingPhase 2

A clinical trial to evaluate the effectiveness of Amukkara chooranam and aya chenduram in the management of aan maladu (oligozoospermia) - A pilot study

DrSESWARI1 site in 1 country10 target enrollmentStarted: May 1, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
changes in the semen parameter after the medication

Study Overview

Brief Summary

Infertility is defined as the ability to achieve pregnancy after 12 months of regular unprotected intercourse, affects upto 15% of couple worldwide. Male factor solely contributes in about 20% of infertility couples or acting in conjugation with female fertility factor in 30% of infertility couples. Oligozoospermia refers specifically to the condition in which sperm concentration below the lower reference limit of 15 million sperm/mL of ejaculate. Oligozoospermia can be further classified as mild (between 10-15 million sperms/mL),moderate (between 5-10 million sperms/mL) and severe ( less than 5 million sperms/mL). According to Siddha Scholar Yugi muni symptoms like semen showing lack of sweetness, floating on water, absence of vitality & frothy micturation indicates Aan maladu [male infertility]. In Siddha, Thathu nashtam [Oligozoospermia] has not been described as a separate disease entity. There is no direct reference for the comparison of Thathu nashtam to oligozoospermia however its feature can be understood on the basis of the indirect references available in the Siddha literatures. The various nomenclature used in siddha texts in relation with Sukkilam the seventh udal thathu [physical constituent] can be compared to sperm and not semen alone since its function is reproducion. The term Thathu Rogam [vinthu vai patria 4 noi] denotes disease relating to sperm and Thathu kuraivu / Thathu pushti kuraivu denotes Oligozoospermia and hence the term Thathu nashtam can be compared to oligozoospermia of contemporary science as both are similar in terminology [oligo-low; zoospermia-spermatozoa in semen ; thathu – sperm; nashtam-lack, be deficient in].

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
22.00 Year(s) to 45.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • 1.Male infertile patients with age between 22-45 years.

Exclusion Criteria

  • 1,Azoospermia-complete absence of sperm in the ejaculate
  • Aspermia-complete lack of semen
  • Necrospermia- spermatozoa in semen are dead
  • History of undescended testis
  • Inguinal hernia on physical examination.

Outcomes

Primary Outcomes

changes in the semen parameter after the medication

Time Frame: At baseline and after 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
DrSESWARI
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

S ESWARI

National Institute of Siddha

Study Sites (1)

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