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

Primary Purpose

Oligospermia

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Chandrakanthi Choornam (CKC)
Sponsored by
Tamil Nadu Dr.M.G.R.Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligospermia focused on measuring Hypospermatogenesis, Low Sperm Count, Oligozoospermia

Eligibility Criteria

21 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • National institute of siddha

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chandrakanthi choornam

Arm Description

Chandrakanthi Choornam (CKC) - 12gm in milk OD dose; Oral route 3 Months - duration Intervention Drug: Chandrakanthi Choornam (CKC)

Outcomes

Primary Outcome Measures

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
Proportion of Sperm motility
Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months
Proportion of Sperm morphology
Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months

Secondary Outcome Measures

Impact on the hormonal level due to the clinical trial
Changes in serum Testosterone, LH and FSH were estimated from baseline to three months

Full Information

First Posted
August 27, 2014
Last Updated
September 4, 2014
Sponsor
Tamil Nadu Dr.M.G.R.Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02234206
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tamil Nadu Dr.M.G.R.Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligospermia
Keywords
Hypospermatogenesis, Low Sperm Count, Oligozoospermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chandrakanthi choornam
Arm Type
Experimental
Arm Description
Chandrakanthi Choornam (CKC) - 12gm in milk OD dose; Oral route 3 Months - duration Intervention Drug: Chandrakanthi Choornam (CKC)
Intervention Type
Drug
Intervention Name(s)
Chandrakanthi Choornam (CKC)
Other Intervention Name(s)
Nerunjil choornam
Intervention Description
12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration Preparation from approved sastric book as per drugs & cosmetic act 1940
Primary Outcome Measure Information:
Title
Sperm concentration per milliliter of seminal fluid
Description
Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months
Time Frame
90 days
Title
Proportion of Sperm motility
Description
Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months
Time Frame
90 days
Title
Proportion of Sperm morphology
Description
Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Impact on the hormonal level due to the clinical trial
Description
Changes in serum Testosterone, LH and FSH were estimated from baseline to three months
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Assessment on Safety parameters
Description
Safety parameters: Liver function test ,Renal function test , Lipid profile, Haematological profile , Blood Glucose, Urinary parameters were assessed from baseline to three months
Time Frame
90 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.B. Akila., M.D (s)
Organizational Affiliation
National institute of Siddha
Official's Role
Principal Investigator
Facility Information:
Facility Name
National institute of siddha
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600047
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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