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

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

Status and phase: Completed; Phase 2

Conditions: Oligospermia

Treatments: Drug: Chandrakanthi Choornam (CKC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02234206

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

CTRI/2014/01/004281 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: Male

Ages: 21 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Chandrakanthi choornam

Experimental group

Description:

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

Treatment:

Drug: Chandrakanthi Choornam (CKC)