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

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

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.

Study Overview

• Status: Completed
• Conditions: Oligospermia
• Intervention / Treatment: Drug: Chandrakanthi Choornam (CKC)

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600047
      • National institute of siddha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Nerunjil choornam

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment on Safety parameters	Safety parameters: Liver function test ,Renal function test , Lipid profile, Haematological profile , Blood Glucose, Urinary parameters were assessed from baseline to three months	90 days

Collaborators and Investigators

• Sponsor: Tamil Nadu Dr.M.G.R.Medical University
• Investigators: Principal Investigator: Dr.B. Akila., M.D (s), National institute of siddha

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): September 9, 2014
• Last Update Submitted That Met QC Criteria: September 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Hypospermatogenesis, Low Sperm Count, Oligozoospermia
• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Oligospermia
• Other Study ID Numbers: Ref.No. ExII(1)/29096/2011; CTRI/2014/01/004281 (Registry Identifier: CLINICAL TRIALS REGISTRY- INDIA)