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

Study Overview
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Brief Summary
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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
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METHODOLOGY OF PROPOSED RESEARCH: I. Preclinical study II. Clinical study I. PRECLINICAL STUDY: Standardization Of The Study Drug Botanical Identification Chemical Identification Preparation of the study drugs: Formulation: Chandrakanthi choornam Source : Chikicharathna deepam Part II. Pg-168 (Approved sastric book as per drugs & cosmetic act 1940. Chemical methods of testing Pharmacological study : A. Spermotogenic Activity 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

Official Title
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Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study

Conditions
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Oligospermia

Intervention / Treatment
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* Drug: Chandrakanthi Choornam (CKC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chandrakanthi choornam<br>Chandrakanthi Choornam (CKC) - 12gm in milk OD dose; Oral route 3 Months - duration Intervention Drug: Chandrakanthi Choornam (CKC) | Drug: Chandrakanthi Choornam (CKC)<br>* 12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration Preparation from approved sastric book as per drugs & cosmetic act 1940<br>* Other names: Nerunjil choornam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm concentration per milliliter of seminal fluid | Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months | 90 days | 
| Proportion of Sperm motility | Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months | 90 days | 
| Proportion of Sperm morphology | Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on the hormonal level due to the clinical trial | Changes in serum Testosterone, LH and FSH were estimated from baseline to three months | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypospermatogenesis, Low Sperm Count, Oligozoospermia