| CTRI Number |
CTRI/2024/07/071016 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of shalmali moola tablets to Increase sperm count |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED STANDARD CONTROLLED CLINICAL TRIAL ON THE EFFECT OF SHALMALI MOOLA (Shalmalia Malabarica. L) TABLET IN OLIGOSPERMIA (KSHEENA SHUKRA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REMESH CHANDRAN TS |
| Designation |
Assistant Professor |
| Affiliation |
CVM UNIVERSITY |
| Address |
Department of Kayachikitsa G.J PATEL INSTITUTE AYURVEDIC STUDIES and RESEARCH &
S.G Patel Ayurvedic hospital and Maternity home New Vallabh Vidyanagar Anand Gujarat India
Anand
GUJARAT
388121
India |
| Phone |
7012236368 |
| Fax |
|
| Email |
remeshchandran39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh S Deole |
| Designation |
Professor |
| Affiliation |
CVM UNIVERSITY |
| Address |
Department of Kayachikitsa G.J PATEL INSTITUTE AYURVEDIC STUDIES and RESEARCH ,
S.G Patel Ayurvedic hospital and Maternity home New Vallabh Vidyanagar Anand Gujarat India
Anand
GUJARAT
388121
India |
| Phone |
997499309 |
| Fax |
|
| Email |
yogesh.deole@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh S Deole |
| Designation |
Professor |
| Affiliation |
CVM UNIVERSITY |
| Address |
Department of Kayachikitsa G.J PATEL INSTITUTE AYURVEDIC STUDIES and RESEARCH ,
S.G Patel Ayurvedic hospital and Maternity home New Vallabh Vidyanagar Anand Gujarat India
Anand
GUJARAT
388121
India |
| Phone |
997499309 |
| Fax |
|
| Email |
yogesh.deole@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| G.J. Patel Institute Of Ayurvedic Studies and Research, New V.V. Nagar, Anand, Pin- 388121 |
|
|
Primary Sponsor
|
| Name |
G.J. Patel Institute Of Ayurvedic Studies and Research |
| Address |
Department of Kayachikitsa G J PATEL INSTITUTE AYURVEDIC STUDIES and RESEARCH S.G Patel Ayurvedic hospital and Maternity home New Vallabh Vidyanagar Anand Gujarat India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrREMESH CHANDRAN T S |
S G Patel Ayurveda Hospital & Maternity home , New Vallabh Vidhya Nagar Anand |
OPD NO:14 , KAYACHIKITSA DEPARTMENT
Anand
GUJARAT |
7012236368
remeshchandran39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G J Patel Institute of Ayurvedic Studies and Research and S G Patel Ayuredic Hospital and Maternity Home , CERTIFiCATE OF APPROVAL OF INSTITUTIONAL -HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: SUKRAKSHAYAH, (2) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, (3) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha tablet, Reference: Bhavaprakasham, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHALMALI , Reference: BHAISHAJYA RATHNAVALI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed cases of oligospermia
Sperm count less than 15 million/ml. |
|
| ExclusionCriteria |
| Details |
Patients with azoospermia & aspermia, Teratospermia more than14%
2.
Patient with known sexually transmitted disease.
3.
Sperm count greater than 15 million/ml.
4.
Systemic diseases like known case of diabetes mellitus will be excluded from the study.
5.
Semen samples showing high viscosity and low liquefaction time. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Analyze the Effect of Shalmali moola tablets on Sperm Count. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Effect of Shalmali moola Tablets on LDL, LH & S.Testosterone. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
As high as 90% of male infertility problems are related to sperm count and there is always a positive association between the abnormal semen parameters and sperm count. But in about 30-40% cases the cause of Oligospermia is unexplained, and in the rest of the cases critical illness, malnutrition, geneticabnormalities, pollution, side effects of some medicines, hormones and chemicals play a major role. The oxidative stress caused by ROS leading to sperm dysfunction, sperm DNA damage and finally resulting in reduced male reproductive potential is an area of great concern in contemporary medicine about seminal morbidities.Considering these aspects, in contemporary medicine as a base line management the routine administration of oral anti-oxidants like L-carnitine, Coenzyme Q-10, etc is being practiced initially9. But there are no established conclusive reports on antioxidants effect in seminal parameters and also the optimal type and dosage of antioxidants are still unknown. And when there is no response to these treatments, other investigations are done and nearly all cases are being suggested for Assisted Reproductive Techniques (ART). Even though the modern science plays an important role for treating the infertility but because of their costly investments they are not reaching to the poor or middle-class people. There are growing concerns that disturbance in hormone levels results in spermatogenesis dysfunction and male infertility. Hormone deficiency in germ cell microenvironments has been indicated as the key reason for immature sperm increase which could adversely affect sperm survival and function. The process of spermatogenesis is thoroughly dependent on downstream hormones secreted in response to gonadotropin-releasing hormone in the hypothalamus-pituitary-testis axis. FSH affects Sertoli cells to produce AMH or serves a direct fundamental role in spermatogenesis through stimulation of cell proliferation, differentiation, and control of surrounding cells apoptosis. However, LH acts on Leydig cells to promote testosterone secretion and affects spermatogenesis via testosterone/androgen. Gonadotropin and testosterone concentrations play significant roles in maintaining normal spermatogenesis receptors. Therefore, in the current study, we investigated the effects of known hormones on Oligospermia to draw a more reliable conclusion.So, in such conditions an effort has been taken to treat Ksheena shukra w.s.r to oligospermia by using Shalmali moola tablets. |