A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
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.
METHODOLOGY OF PROPOSED RESEARCH:

 I. Preclinical study II. Clinical study

 I. PRECLINICAL STUDY:

 Standardization Of The Study Drug

 1. Botanical Identification

 2. Chemical Identification

 3. Preparation of the study drugs:

 Formulation: Chandrakanthi choornam Source : Chikicharathna deepam Part II. Pg-168
 (Approved sastric book as per drugs & cosmetic act 1940.

 4. Chemical methods of testing

 5. Pharmacological study : A. Spermotogenic Activity

 6. Toxicological study : A. Acute Toxicity B. Long term Toxicity

 II. CLINICAL STUDY

 Conducted as per the guidelines of GCP accepted by Ayush adapted from the ICH.

 A. Pilot study B. Main study
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