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CTRI Number  CTRI/2019/04/018819 [Registered on: 29/04/2019] Trial Registered Prospectively
Last Modified On: 04/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the efficacy of Shivagutika in Oligospermia 
Scientific Title of Study   Pharmaceutical analytical and clinical study of Shiva Gutika wsr to Oligospermia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akhilesh Shrivastava 
Designation  PhD Scholar Ayurveda 
Affiliation  Mandsaur Institute of Ayurved Education &Research/Mandasour University 
Address  Dept of Ayurveda room no 1 Mandsaur Institute of Ayurved Education and Research Mandsaur university
Dept of Ayurveda room no 41 Shubhdeep Ayurveda medical college Indore MP 452020
Indore
MADHYA PRADESH
458001
India 
Phone  9993281713  
Fax    
Email  drshrivastava.akhilesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayashankar Mund MD AYU PHD 
Designation  Professor and HOD 
Affiliation  Mandsaur Institute of Ayurved Education &Research/Mandasour University 
Address  Department of Samhita Siddhant Mandsaur Institute of Ayurved Education and Research Mandsaur

Mandsaur
MADHYA PRADESH
458001
India 
Phone  8281932485  
Fax    
Email  principal.ayurved@meu.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR Pronab Haladr MD AYU PHD 
Designation  Associate professor and HOD 
Affiliation  Mandsaur Institute of Ayurved Education &Research/Mandasour University 
Address  Department of Rasa Shastra and Bhaishjya Kalpana Institute of Ayurved Education and Research Mandsaur

Mandsaur
MADHYA PRADESH
458001
India 
Phone  961241120  
Fax    
Email  drpronabhaldar@gmail.com  
 
Source of Monetary or Material Support  
Akhilesh Shrivastava Phd Scholar, Mandsaur Institute of Ayurved Education and Research Mandsaur,Mhow-Neemach Road, Nahata Marg,oppo to Krishi Upaj Mandi, Mandaur Madhya Pradesh 458001 
 
Primary Sponsor  
Name  Mandsaur Institute of Ayurved Education and Research Mandsaur 
Address  Mandsaur Institute of Ayurved Education and Research Mandsaurdistrict madhyapadesh-458001  
Type of Sponsor  Private medical college 
 
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 
Akhilesh Shrivastava  Shubhdeep Ayurved Medical College Indore Madhyapradesh  Dept of Ayurveda room no 41,Shubhdeep Ayurved Medical College ,Khandwa road , Indore 452002 Madhyapradesh
Indore
MADHYA PRADESH 
9993281713

drshrivastava.akhilesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Iinstitutional ethical committee mandsour university  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 
Comparator Agent  NA  NA 
Intervention  SHIVA GUTIKA  The patient of low sperm count below Than 20 million will be administered Tab-Shiva Gutila 500mg bd with milk will be asses after 15 days ,31st day n 60th day of study  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Patient Diagnosed with oligospermia as per ICD10 N46.1 Diagnostic Criteria


 
 
ExclusionCriteria 
Details  1. Patients with evidence of malignancy.
2. Current history of Ischemic heart disease,
3. Chronic kidney disease, Diabetes Mellitus,
4.High Cholesterol and any
5. Other critical illness which may require hospitalization & critical care.
6. Patients take such as medicine which has anti oligozoospermia effect also.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A. Subjective Criteria - A scoring pattern will be adopted for the sign and symptoms of Ksheen Shukra mentioned in Ayurvedic texts. The score of symptoms will be assessed before and after the treatment and statistical analysis will be undertaken.

1. Daurbalya (General Weakness)
2. Mukh Sosha (Dryness of mouth)
3. Alpa Cheshta (Lack of Libido)
B. Objective Criteria: - Sperm Count before and after treatment.

 
30th day
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   29/04/2019 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

                                

                                 Infertility is a common problem of present scenario. The predominant concern with population control in recent years has tended to over-shadow the importance of involuntary sterility as a medical issue. On an average about 10% of all couples face difficulty in starting a family and this creates a feeling of great personal failure, particularly in India where religious and socio-economic traditions have made it almost imperative for everyone to have children.

                                 One of the most common cause of male infertility is Oligozoospermia. The term Oligozoospermia is the presence of an abnormally low number of sperm in a semen sample. The diagnosis method consists of a semenogram which gives a sperm count per millimetre of semen. According to recent criteria of Semen Analysis generated by ICD10 N46.1 sperm count less than 20 million sperms/ml is an indication of Oligozoospermia.

                                In Modern medicine there are various medications used to treat Oligozoospermia including Clomiphene Citrate, Tomoxifen, Testosterone, Acetyle-L-Carnitine but they have their own limitations and side-effects.

                              There are several researches done to find a solution for this problem of today and many of them have proved successful too. Ayurveda provides best treatment to combat with this problem.

                            Oligozoospermia resembles Ksheen Shukra in Ayurvedic literature and Shiva Gutika consists of all the ingredients which directly work on Shukra Dhatu and helps in improving its quality and quantity.

                           In order to generate preliminary evidences about the efficacy of Shiva Gutika in the management of Oligozoospermia, a pre and post open clinical trial is proposed. Thirty eligible study subjects meeting inclusion criteria with baseline sperm count less than 20 million/ml analysed through Semen Analysis. In a single group of sample size of n= 30 will be administered 8 weeks(60 days) of Shiva Gutika tablets in the dose of 500mg twice daily with luke warm milk and the treatment will be concluded with post-test assessment on the 60th day. 

                          Study subjects will be assessed before and after treatment for improvement, comparison and analysis will be done by using Student’s t- Test.

 
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