| CTRI Number |
CTRI/2025/01/079242 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the Effect of Homoeopathic Medicines in Low Sperm Count |
|
Scientific Title of Study
|
A Randomized Double arm Open labelled Comparative Study to Evaluate the Effectiveness of Homoeopathic Medicines in the Treatment of Oligospermia Patients |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CEEBA MARY FERNANDEZ |
| Designation |
MEDICAL OFFICER |
| Affiliation |
Government Homoeo Hospital |
| Address |
Ward 38
Homoeopathy OPD
Ground Floor
Main Block
Government Homoeo Hospital
Keerikad Village South
Near Ikaya Junction
Kayamkulam
Alappuza
Alappuzha KERALA 690502 India |
| Phone |
9895519085 |
| Fax |
|
| Email |
ceebamf@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR VENKATESAN H |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No 3d1,
Medical Unit IV,
Ground Floor, OPD Block,
Vinayaka Missions Homoeopathic Medical College and Hospital,
NH 47, Sankari Main Road,
Seeragapadi PO,
Salem TAMIL NADU 636308 India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR VENKATESAN H |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room No 3d1,
Medical Unit IV,
Ground Floor, OPD Block,
Vinayaka Missions Homoeopathic Medical College and Hospital,
NH 47, Sankari Main Road,
Seeragapadi PO,
Salem TAMIL NADU 636308 India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeo Hospital, Kayamkulam, Keerikad South, Alappuzha, Kerala, Pin Code 690502 |
|
|
Primary Sponsor
|
| Name |
CEEBA MARY FERNANDEZ |
| Address |
Medical Officer, Government Homoeo Hospital, Kayamkulam, Keerikad South, Alappuzha, Kerala, Pin Code 690502 |
| Type of Sponsor |
Other [Government Homoeo Hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vinayaka Missions Research Foundation Deemed to be University |
NH47, SankariMain Road, Ariyanoor PO, Salem, Tamilnadu -
636308 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ceeba Mary Fernandez |
Government Homoeo Hospital |
Ward 38,
Ground Floor,
Main Block,
Keerikad village,
Near Ikaya junction,
Kayamkulam
Pin Code 690502
Alappuzha KERALA |
9895519085
ceebamf@gmail.com |
| Dr Venkatesan H |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No : 3 D1, Medical Unit IV
Dept of Practice of Medicine OPD Unit, Ground Floor,Hospital Block,
VMHMCH, NH47,
Sankari Main Road,
Seearagapadi PO,
Pin Code - 636308 Salem TAMIL NADU |
9865134561
venkathompath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bishop Benziger College of Nursing Institutional Ethics Committee |
Approved |
| Vinayaka Missions Kirubanandha Variyar Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tribulus terrestris Mother Tincture |
10 Drops in 15 ml of water orally 3 Times per day for 180 Days to each Patinet |
| Comparator Agent |
Tribulus terrestris Mother Tincture with Indicated Homoeopathic Medicine |
10 Drops in 15 ml of water orally 3 Times per day along with 5 Medicated Globules of 30 Size Indicated Homoeopathic Medicine will be prescribed orally for 180 Days to each Patinet |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Patients who do not use contraceptives, having semen with normal pH and viscosity, with spermatozoa concentration of 5 to 20 million per ml, with spermatozoa mobility Category A less than 25 Percentage or Category A Plus B lessthan 50 Percentage, with normal spermatozoa morphology and Otherwise physically and mentally healthy |
|
| ExclusionCriteria |
| Details |
Patients with structural genital and genetic disorders, Azoospermia and Aspermia, Psychiatric complaints and Sexually Transmitted Diseases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Sperm Count, Improvement in Sperm Morphology and Increase in Sperm Motility |
At Base Line, At the End of 3rd Month and 6th Month of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Fertility Quolity Of Life Score |
180 Days |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
India is seeing a
lowering sperm count trend that has been observed across the globe. This low
sperm counts or Oligospermia can be caused by medical conditions or by
sedentary life style that is wide spread (Agarwal et al., 2021). Oligospermia
can cause difficulty in Infertility as well as difficulty in Conceiving , as
well causing Psychological Distress also affecting the Quality of Life(Li et al., 2019). Smoking, Alcohol consumption, drugs, improper diet,
lack of exercise causing Obesity and ad Stress are some Life style Factors
associated with a low Sperm count. Stress, a major Health concern in recent
times can lead to life style and routine changes(McGrady, 1984). It could cause
sudden weight changes and disrupt sleep and fertility cycles as well. Several
medical conditions, sexually transmitted diseases and hormonal imbalances can
also affect the sperm count. Varicocele retrograde ejaculation could lower the
sperm count(Zeinali et al., 2017). In certain cases lifestyle changes like
limiting alcohol, smoking, drugs, make a shift to healthy diet and do routine
exercise and reduce stress and improve sperm count.
It is estimated
that infertility affects
8–12% of couples globally, with a male factor being a primary or contributing
cause in approximately 50% of couples. (Agarwal et al., 2021). TheASMFR
based estimate of expected level of infertility for the State of Kerala was 61
per 1000 for every married woman in the reproductive ages. Kerala a southern
state in India had achieved replacement level fertility in the late 1980s, and
then its Total Fertility Rate (TFR) has shown a steady decline. Currently the
state is experiencing a below replacement level fertility with TFR of 1.8in
2019-21 (Thomas & Ramanathan, 2022). There is
growing evidence that lifestyle choices account for the overall quality of
health and life (QoL) reflecting many potential lifestyle risks widely
associated with alterations of the reproductive function up to the infertility. (Ilacqua
et al., 2018).
Homoeopathy is one of
the safest forms of treatment for male infertility. The success rate of this
treatment for male infertility is promising. Additionally, homoeopathic drugs
increase sperm count and sperm abnormalities. Homoeopathic medicines which are
found to be effective in male infertility or sperm count abnormalities are,
Caladium, Conium Maculatum, X-ray, Agnus Castus, Selenium, Cobaltum, Titanium
and so on.(Js, n.d.).
REVIEW OF LITERATURE: -
Male
factor infertility is described as presence of one or more abnormalities in the
sperm analysis as well as poor sexual or ejaculatory function. Male aging results in the loss of antioxidant
activity and elevated levels of ROS. This imbalance between ROS and
antioxidants causes oxidative stress and is well documented in the male
reproductive tract and in the spermatozoa of aging rodents (Mueller et al.,
1998) If not maintained within normal physiological levels, ROS can damage
cellular macromolecules, inducing stress signalling and, at high levels, cell
death.
In
humans, although spermatozoa are continuously produced with advanced paternal
age, there is a growing body of evidence indicating that advanced paternal age
is associated with negative impact on the quality of male germ cells (Lawson
& Fletcher, 2014) the number of Sertoli cells and the number of Leydig cells (NEAVES et al.,
1984). In a study it was found that compared to the age group 18–40 years, men
aged > 75 years had 31% smaller mean testicular volume. (Johnson et al.,
1988) In addition, some authors reported the thickening of basal membrane of
seminiferous tubules with age as well as
disturbances in blood supply in senile testes have been associated with
negative changes in spermiogenesis and thickness of basement membrane. Male
aging is characterized by different changes in the endocrine function. Hormonal
changes are characterized mainly by a reduction of the biosynthesis of
testicular inhibin B by Sertoli cells with increased secretion of follicle
stimulating hormone (FSH). Leydig cells are responsible for testosterone
production. The number of Leydig cells tends to reduce with increasing paternal
age . The average total number of Leydig cell nuclei decreases by half in age
group of 50–76 years compared to age group of 20–48 years. Wu et al. reported
that age-affected testicular atrophy is a result of Hypothalamic-Pituitary-Testicular
Axis alterations that disturb the function. (NEAVES et al., 1984).
Tribulus
terrestris L. is an herbal plant
that has long been used as sex stimulant and to treat male infertility. This systematic review collected the clinical trials
and/or quasi-experimental studies on the effect of T. terrestris on
sperm parameters in idiopathic male infertility. To search the related
articles, Cochrane Library, EMBASE, ProQuest, Clinicaltrial.gov, WHO, Google
Scholar, MEDLINE via Pubmed, Web of Science, SID, Magiran, Irandoc, and
Iranmedex databases were used without any time limitation. Words used to search
were T. terrestris L., Tribestan, male infertility and sperm
parameters based on the MeSH glossary. To assess the eligibility of the
articles, the views of the two authors and in cases where there was no
agreement, the third person was used. Through searching of the databases, 5775
articles were identified, of which 3509 were entered after removing the
duplicates. Afterward, 102 articles were screened for inclusion. Finally, 7
articles were included in this systematic review. Only one quasi-experimental
without control arm article reported that the use of T. terrestris L.
in the treatment of idiopathic male infertility was not effective, In the
others, T. terrestris L. was reported to be effective in
improving some or all parameters of the sperm, namely number, motility and
morphology.The results of the present systematic review showed that the
consumption of T terrestris L., in general, resulted in the
improvement of sperm parameters. This result was obtained from 6 out of the 7
articles.(Sanagoo et
al., 2019). Scientific evidence supports the use of mucuna and ashwagandha as
phytotherapics for improving serum T concentrations and semen parameters.
Despite inconclusive evidence for use of tribulus as a T booster, it may
provide advantageous effects on sperm parameters in men with idiopathic
infertility.(Santos et
al., 2019). |