Clinical trial NCT02234206: A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
Official title: Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oligospermia
Keywords: Hypospermatogenesis, Low Sperm Count, Oligozoospermia
Lead sponsor: Tamil Nadu Dr.M.G.R.Medical University
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 40
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: Sperm concentration per milliliter of seminal fluid
timeFrame: 90 days
measure: Proportion of Sperm motility
timeFrame: 90 days
measure: Proportion of Sperm morphology
timeFrame: 90 days
Secondary outcomes:
measure: Impact on the hormonal level due to the clinical trial
timeFrame: 90 days
Other outcomes:
measure: Assessment on Safety parameters
timeFrame: 90 days
Locations:
city: Chennai
country: India
facility: National institute of siddha
state: Tamilnadu
Study officials:
affiliation: National institute of Siddha
name: Dr.B. Akila., M.D (s)
role: PRINCIPAL_INVESTIGATOR
References: