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NCT Number: NCT02234206

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.

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Key information

Conditions

Oligospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

National institute of siddha

Chennai, Tamil Nadu, 600047, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chandrakanthi Choornam (CKC)

Drug

12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration

Preparation from approved sastric book as per drugs & cosmetic act 1940

Other names: Nerunjil choornam

Primary outcomes

  1. Sperm concentration per milliliter of seminal fluid

    Time frame: 90 days

    Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months

  2. Proportion of Sperm motility

    Time frame: 90 days

    Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months

  3. Proportion of Sperm morphology

    Time frame: 90 days

    Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months

Secondary outcomes

  1. Impact on the hormonal level due to the clinical trial

    Time frame: 90 days

    Changes in serum Testosterone, LH and FSH were estimated from baseline to three months

Other outcomes

  1. Assessment on Safety parameters

    Time frame: 90 days

    Safety parameters: Liver function test ,Renal function test , Lipid profile, Haematological profile , Blood Glucose, Urinary parameters were assessed from baseline to three months

Sponsors and collaborators

Lead sponsor

Tamil Nadu Dr.M.G.R.Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2014
Registry last updated
Sep 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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