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CTRI Number  CTRI/2023/12/060647 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
Dried Moringa seeds improve male reproductive health  
Scientific Title of Study
Modification(s)  
Clinical Evaluation of Dried Moringa Seeds, Safed Musli and Velvet Bean in Male Infertility: A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Khartode 
Designation  Chief Dietitian 
Affiliation  Vishwaraj Hospital 
Address  OPD No-7, Ground floor, Vishwaraj Hospital, Near Loni Station, Pune- solapur highway, next to hadapsar, Loni

Pune
MAHARASHTRA
412210
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietitian 
Affiliation  Vishwaraj Hospital 
Address  OPD No-7, Ground floor, Vishwaraj Hospital, Near Loni Station, Pune- solapur highway, next to hadapsar, Loni

Pune
MAHARASHTRA
412210
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietitian 
Affiliation  Vishwaraj Hospital 
Address  OPD No-7, Ground floor, Vishwaraj Hospital, Near Loni Station, Pune- solapur highway, next to hadapsar, Loni

Pune
MAHARASHTRA
412210
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Source of Monetary or Material Support  
Vishwaraj hospital 
 
Primary Sponsor  
Name  Vishwaraj hospital 
Address  Near Loni Station, Pune- solapur highway, next to hadapsar, Loni 412210 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swati Khartode  Vishwaraj Hospital,   Near Loni Station, Pune- solapur highway, next to hadapsar, Loni, 412210
Pune
MAHARASHTRA 
9767133699

opd@vrhpune.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee MAEER’s Vishwaraj Hospital Ethics Committee  Approved 
MAEERS Vishwaraj Hospital   Approved 
MAEERS Vishwaraj Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N539||Unspecified male sexual dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dried Moringa seeds powder  Dried moringa seeds powder Dose: 15 gms daily once Duration: 2 months daily once 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Confirmed diagnosis of Impaired mala reproductive system by Clinical examination, semen analysis for sperm count, male patients of 18-55 years. 
 
ExclusionCriteria 
Details  1. Chronic Kidney disease (CKD)
2. Intestinal mal absorption disorders like colitis, IBS etc 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improved Semen analysis after 2 months of nutritional intervention of Dried Moringa seeds powder  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To check relief in symptoms occurred due to erectile dysfunction or oligospermia
 
2 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "304"
Final Enrollment numbers achieved (India)="304" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   29/12/2023 
Date of Study Completion (India) 15/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Introduction:

The male reproductive system consists of the internal structures: the testes, epididymis, vas deferens, prostate, and the external structures: the scrotum and penis. These structures are well-vascularized with many glands and ducts to promote the formation, storage, and ejaculation of sperm for fertilization, and to produce important androgens for male development. The major male androgen is testosterone, which is produced from Leydig cells in the testes (Gurung, P., Yetiskul, E., & Jialal, I. (2022), that maintain male reproductive function and promote spermatogenesis and transport into the female reproductive system for fertilization. The testes act as both endocrine and exocrine organs in that they are responsible for androgen production and sperm production and transport (Gurung, P., Yetiskul, E., & Jialal, I. (2022).

Common tests of male reproductive function include a blood test to measure testosterone levels. Total testosterone ranges from 300 to 1000 ng/mL. Other tests include semen analysis, which establishes fertility status and function of the seminiferous tubules, epididymis, and accessory sex glands.

Background and Purpose of study:

Disorders of the male reproductive system typically result from decreased testosterone levels or insensitivity to testosterone, which lead to low libido, failure to ejaculate, decrease in bone density, muscle loss, infertility, loss of body hair and, importantly, incomplete sexual development if the disorder is congenital or acquired before puberty. Other less specific symptoms of low testosterone include low energy/depressed mood, anemia or increased body fat. Other comorbidities associated with low testosterone include metabolic syndrome, insulin resistance, and atherosclerosis (Gurung, P., Yetiskul, E., & Jialal, I. (2022).

Prevalence: In the elderly, testosterone deficiency is associated with low bone mass and therefore imply an increased risk of osteoporotic fractures (Aggarwal, V., Menon, A. S., & Verma, V. (2022). Chronic and severe alcohol dependence increases the chances of developing sexual dysfunctions (Bhainsora, R. S., et all. (2021). The prevalence of Erection Dysfunction is high among T2 DM patients (Talwar, V., & Talwar, G. (2021).

Role of Diet in Male reproductive system: Environmental and lifestyle factors, diet, exposure to radiation and several other factors may affect the male reproductive system. It is evident that most of these factors contribute to male infertility via induction of oxidative stress (Agarwal, A.,et al (2020).  The mammalian system needs a continuous supply of certain trace elements, one of which is Se. In addition to other vital functions, Se is involved in male reproduction. The morphology of male reproductive organs strongly depends upon the adequate dietary supply of Se (Ahsan, U., et al. 2014) One study done on diabetic rats stated that Intake of ginger roots improves the antioxidant and androgenic reproductive function of male diabetic rats in addition to its anti-diabetic property (Ghlissi, et al. 2013).

One study done by Varsha S. Zade, et al in 2013 on albine male rats by giving them aqueous extract of the seeds M. oleifera confirms that ingestion of aqueous extract of moringa seeds produce increased effects on fertility and reproductive system in adult male rat. It also lends support to the claims for traditional usage of M. oleifera as a sexual function enhancing medicine. Thus, this study may prove to be an effective and safe alternative remedy in sexual disorders. Work is in progress on the isolation and characterization of the spermatogenic principle in the plant extract.

Thus we have seen that there are many health benefits of Moringa oleifera seeds, but appropriate processing methods should be adopted on M. oleifera seeds to reduce or eliminate the anti-fertility components or contraindications thereby making it a more acceptable food product (Anagonye Callistus, O. (2017).

Finally, the seeds of M. oleifera contain numerous phytochemical compounds with pharmacological activity. However, this activity is reported in the literature only for animal and cellular models, there has been no study of their pharmacological activity in humans. Therefore, we will conduct a clinical trial with nutrition intervention by dried moringa seeds powder in impaired Male reproductive system patients with the purpose of whether there is any improvement in male reproductive system disorders.

 

 
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