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CTRI Number  CTRI/2024/09/073375 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on the Link Between Iron Deficiency Anemia and Reduced Semen Quality Analyzing Iron Levels and Semen Health 
Scientific Title of Study   An analytical cross- sectional study to evaluate the correlation of Pandutva (Iron deficiency Anemia) in Shukra Kshaya through iron profile and semen analysis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Loveena 
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital  
Address  A 107 Department of Rog Nidana Evum Vikriti Vigyana

Chandigarh
CHANDIGARH
160047
India 
Phone  9888564384  
Fax    
Email  loveena3655@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Loveena 
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital  
Address  A 107 Department of Rog Nidana Evum Vikriti Vigyana

Chandigarh
CHANDIGARH
160047
India 
Phone  9888564384  
Fax    
Email  loveena3655@gmail.com  
 
Details of Contact Person
Public Query  
Name  Loveena 
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital  
Address  A 107 Department of Rog Nidana Evum Vikriti Vigyana

Chandigarh
CHANDIGARH
160047
India 
Phone  9888564384  
Fax    
Email  loveena3655@gmail.com  
 
Source of Monetary or Material Support  
Laboratory of Shri Dhanwantry Ayurvedic college and hospital sector 46 b chandigarh pin code 160047 India 
 
Primary Sponsor  
Name  Dr Loveena 
Address  A 107 Department of Rog Nidana Evum Vikriti Vigyana 
Type of Sponsor  Other [Self] 
 
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 Loveena  Shri Dhanwantry Ayurvedic College and Hospital  A 107 Department of Rog Nidana Evum Vikriti Vigyana Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh
Chandigarh
CHANDIGARH 		 9888564384

loveena3655@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SHRI DHANWANTRY AYURVEDIC COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N469||Male infertility, unspecified. Ayurveda Condition: SUKRAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Male patients between age group of 21 to 60 years
Subjects having any kind of abnormalities in semen analysis for case group and subjects with normal semen analysis for control group
Person able to give sample
 
 
ExclusionCriteria 
Details  • All congenital and surgical cases of impotency.
Patients with any major systemic illness such as Diabetes Mellitus, Hypertension, HIV, STD etc
Patients with other forms of anaemia, haemoglobinopathies, any malignancy and aplastic anaemia
Patients on any kind of medication that can alter investigation results required for study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the relation of Pandutva in Shukra Kshaya by assessing iron profile and semen analysis in the subjects  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the Dosha predominance in subjects by evaluating semen sample with Shukra Dushti Lakshanas.
2. To find out the possible mechanism for obtained outcome 		 baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/12/2024 
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="1"
Months="4"
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  

“An analytical cross- sectional study to evaluate the correlation of Pandutva (Iron deficiency Anemia) in Shukra Kshaya through iron profile and semen analysis”

INTRODUCTION: In Charaka Samhita, various Shukra Kshaya lakshanas have been explained and one among them is Pandutva. So, an attempt is made to find correlation of Pandutva in Shukra Kshaya by observing the correlation of Semen Analysis and Iron profile. Efforts are made to revalidate the concepts of ayurveda and explain the possible mechanism of the outcome through the lens of ayurveda.

LITERATURE REVIEW:

दौर्बल्यं मुखशोषश्च पाण्डुत्वं सदनं श्रमः। क्लैब्यं शुक्राविसर्गश्च क्षीणशुक्रस्य लक्षणम् ॥ (Ch. Su. 17/69)

AIMS: To evaluate the correlation of Pandutva(Iron deficiency Anaemia) in Shukra Kshaya through iron profile and semen analysis.

OBJECTIVES:

Primary objective: To find the relation of pandutva in shukra kshaya by assessing iron profile and semen analysis in the subjects.

Secondary objective: 1. To study the dosha predominance in subjects by evaluating semen sample with shukra dushti lakshanas. 2.To find out the possible mechanism for obtained outcome.

MATERIALS AND METHODS:

An Analytical cross- sectional study will be done on 60 patients (30 in case group and 30 in control group). Subjects desired for the study will be taken from OPD &IPD of Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh and associated institutes. Semen sample and blood sample will be collected for the semen analysis and iron profile test respectively. Patients having de-arranged semen analysis will be enrolled for case group and those who will be having normal semen analysis will be enrolled for control group in the study. Assessment of result reports of both the tests will be done to evaluate any correlation between the findings.

 
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