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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02234206

Enrollment

Registered

2014-09-09

Start date

2012-12-31

Completion date

2014-08-31

Last updated

2014-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligospermia

Keywords

Hypospermatogenesis, Low Sperm Count, Oligozoospermia

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

Interventions

DRUGChandrakanthi Choornam (CKC)

12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration Preparation from approved sastric book as per drugs & cosmetic act 1940

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Sperm concentration per milliliter of seminal fluid	90 days	Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months
Proportion of Sperm motility	90 days	Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months
Proportion of Sperm morphology	90 days	Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months

Secondary

Measure	Time frame	Description
Impact on the hormonal level due to the clinical trial	90 days	Changes in serum Testosterone, LH and FSH were estimated from baseline to three months

Other

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026