Overview

A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
Male
Summary
This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in 40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25 ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed, Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum, Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit, Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and morphology. Secondary Outcome measure is to see the impact on the harmone level.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tamil Nadu Dr.M.G.R.Medical University
Criteria
Inclusion criteria:

- Male infertile Patients with age between 21-45 yrs

- Marriage history for >1 year

- Abnormal Sperm count 1-15 million/ml

- Patients with normal Liver & Renal function test

- Willing to give specimen of semen before & at the end of the clinical trial

- Informed patients giving written consent

Exclusion criteria:

- Azoospermia - complete absence of sperm cells in the ejaculate

- Aspermia - complete lack of semen

- Necrospermia- Spermatozoa in semen are either immobile or dead.

- Clinical diagnosis of Varicocele & Hydrocele

- History of Undescended testis

- Inguinal hernia on physical examination

- Male accessory gland infection

- History of DM, Hypertension and Cardiac disease

- Any recent medical or surgical illness

- Underwent treatment for promoting Spermatogenic fertility in last 3 months

- Other Systemic disease requiring specific therapies

- Known Thyroid disease

- Past history of Renal, Hepatic or any other chronic illness in the Patient