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

NCT ID: NCT02234206

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-08-31

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

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

Conditions

Oligospermia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chandrakanthi choornam

Chandrakanthi Choornam (CKC) - 12gm in milk

OD dose; Oral route

3 Months - duration

Intervention Drug: Chandrakanthi Choornam (CKC)

Group Type: EXPERIMENTAL

Chandrakanthi Choornam (CKC)

Intervention Type: DRUG

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

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Nerunjil choornam

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Dr.B.Akila., M.D (s)

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.B. Akila., M.D (s)

Role: PRINCIPAL_INVESTIGATOR

National institute of Siddha

Locations

National institute of siddha

Chennai, Tamil Nadu, India

Countries

India

Other Identifiers

CTRI/2014/01/004281

Identifier Type: REGISTRY

Identifier Source: secondary_id

Ref.No. ExII(1)/29096/2011

Identifier Type: -

Identifier Source: org_study_id