NCT02234206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
Last Updated

September 9, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

August 27, 2014

Last Update Submit

September 4, 2014

Conditions

Oligospermia

Keywords

Hypospermatogenesis, Low Sperm Count, Oligozoospermia

Outcome Measures

Primary Outcomes (3)

  • 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

  • Proportion of Sperm motility

    Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months

    90 days

  • Proportion of Sperm morphology

    Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months

    90 days

Secondary Outcomes (1)

  • Impact on the hormonal level due to the clinical trial

    90 days

Other Outcomes (1)

  • Assessment on Safety parameters

    90 days

Study Arms (1)

Chandrakanthi choornam

EXPERIMENTAL

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

Drug: Chandrakanthi Choornam (CKC)

Interventions

Chandrakanthi Choornam (CKC)DRUG

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

Also known as: Nerunjil choornam
Chandrakanthi choornam

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institute of siddha

Chennai, Tamil Nadu, 600047, India

Location

MeSH Terms

Conditions

Oligospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Dr.B. Akila., M.D (s)

    National institute of Siddha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study

Study Record Dates

First Submitted

August 27, 2014

First Posted

September 9, 2014

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

September 9, 2014

Record last verified: 2014-08

Locations

IN(1)