Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234206
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.B.Akila., M.D (s), Tamil Nadu Dr.M.G.R.Medical University

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.

Condition or disease Intervention/treatment Phase
Oligospermia Drug: Chandrakanthi Choornam (CKC) Phase 2

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study
Study Start Date : December 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Chandrakanthi choornam

Chandrakanthi Choornam (CKC) - 12gm in milk

OD dose; Oral route

3 Months - duration

Intervention Drug: Chandrakanthi Choornam (CKC)

Drug: Chandrakanthi Choornam (CKC)

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

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

Other Name: Nerunjil choornam




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234206


Locations
Layout table for location information
India
National institute of siddha
Chennai, Tamilnadu, India, 600047
Sponsors and Collaborators
Tamil Nadu Dr.M.G.R.Medical University
Investigators
Layout table for investigator information
Principal Investigator: Dr.B. Akila., M.D (s) National institute of Siddha

Layout table for additonal information
Responsible Party: Dr.B.Akila., M.D (s), Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study, Tamil Nadu Dr.M.G.R.Medical University
ClinicalTrials.gov Identifier: NCT02234206     History of Changes
Other Study ID Numbers: Ref.No. ExII(1)/29096/2011
CTRI/2014/01/004281 ( Registry Identifier: CLINICAL TRIALS REGISTRY- INDIA )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: August 2014

Keywords provided by Dr.B.Akila., M.D (s), Tamil Nadu Dr.M.G.R.Medical University:
Hypospermatogenesis, Low Sperm Count, Oligozoospermia

Additional relevant MeSH terms:
Layout table for MeSH terms
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male