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OligospermiaPhase 2NCT02234206

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

A Phase 2 study testing Chandrakanthi Choornam (CKC) in people with Oligospermia, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 45 years, men only
Conditions the study is for
Oligospermia
What is being tested?
Chandrakanthi Choornam (CKC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndia
Study dates
Dec 2012to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

India1 site

  • National institute of siddha

    Chennai, Tamil Nadu, 600047

Other trials in India

About this study

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

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.

Read the detailed description

METHODOLOGY OF PROPOSED RESEARCH:

  1. Preclinical study II. Clinical study
  2. 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.

  1. Pilot study B. Main study
Conditions
Oligospermia
Being tested
Chandrakanthi Choornam (CKC)
Keywords
Hypospermatogenesis, Low Sperm Count, Oligozoospermia
Medical subject headings
Oligospermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chandrakanthi Choornam (CKC)Drug

    Also called Nerunjil choornam

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

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

Study groups in NCT02234206
Study groupRoleWhat they receive
Chandrakanthi choornamExperimentalChandrakanthi Choornam (CKC) - 12gm in milk OD dose; Oral route 3 Months - duration Intervention Drug: Chandrakanthi Choornam (CKC)
Receives: Drug: Chandrakanthi Choornam (CKC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 90 days

  2. Proportion of Sperm motility

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

    Measured: 90 days

  3. Proportion of Sperm morphology

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

    Measured: 90 days

Secondary outcomes (1)

  1. Impact on the hormonal level due to the clinical trial

    Changes in serum Testosterone, LH and FSH were estimated from baseline to three months

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2014 (estimated)
  2. Study startDec 2012
  3. Primary completionApr 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02234206
Sponsor's protocol ID
Ref.No. ExII(1)/29096/2011
Other IDs
CTRI/2014/01/004281
Status last verified
Aug 2014
First submitted
27 Aug 2014
Last updated
9 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chandrakanthi Choornam (CKC) in people with Oligospermia, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sperm concentration per milliliter of seminal fluid (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02234206.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.

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