| 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
|
|
|
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
|
|
|
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
|
|
|
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. |