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

Oligospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234206
• Other study ID #: Ref.No. ExII(1)/29096/2011
• Secondary ID: CTRI/2014/01/004
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2014
• Last updated: September 4, 2014
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Tamil Nadu Dr.M.G.R.Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oligospermia

Intervention

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

Locations

Country	Name	City	State
India	National institute of siddha	Chennai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Tamil Nadu Dr.M.G.R.Medical University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	No
Primary	Proportion of Sperm motility	Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months	90 days	No
Primary	Proportion of Sperm morphology	Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months	90 days	No
Secondary	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	No