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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  
Status 
Not Applicable 
 
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)

 
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