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CTRI Number  CTRI/2021/05/033718 [Registered on: 21/05/2021] Trial Registered Prospectively
Last Modified On: 18/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   BODY ADEPOSITY INDEX AND INFERTILITY 
Scientific Title of Study   CORRELATION OF SHRONI VISTARA (HIP CIRCUMFERENCE) AND BODY ADIPOSITY INDEX WITH STRI BANDHYATVA (FEMALE INFERTILITY)- A CROSS SECTIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR AMRISH CHANANA 
Designation  ASSISTANT PRFESSOR 
Affiliation  GGSIPU 
Address  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI
CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI
North West
DELHI
110073
India 
Phone  08383028675  
Fax    
Email  amrish.chanana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  BUSHRA PARVEEN 
Designation  MD SCHOLAR ( DEPT. OF ARACHANA SHARIR) 
Affiliation  GGSIPU 
Address  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI NORTHWEST DELHI 110073 INDIA
CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI
North West
DELHI
110073
India 
Phone  9205650725  
Fax    
Email  bushra.9323@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR BUSHRA PARVEEN 
Designation  MD SCHOLAR ( DEPT. OF ARACHANA SHARIR) 
Affiliation  GGSIPU 
Address  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI NORTHWEST DELHI 110073 INDIA
CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI
North West
DELHI
110073
India 
Phone  9205650725  
Fax    
Email  bushra.9323@gmail.com  
 
Source of Monetary or Material Support  
OPD/IPD OF CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
 
Primary Sponsor  
Name  CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN 
Address  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH NEW DELHI NORTHWEST DELHI 110073 INDIA 
Type of Sponsor  Government 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 
AMRISH CHANANA  GYNECOLOGICAL OPD/IPD OF CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN  CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR, NAJAFGARH, DELHI
South West
DELHI 
08383028675

amrish.chanana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CBPACS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E65||Localized adiposity. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  PREGNANT FEMALES OF FIRST TRIMESTER OF AGE 20- 40 YR
BOTH PRIMARY OR SECONDRY INFERTILE FEMALE 
 
ExclusionCriteria 
Details  FEMALE HAVING ANY CONGENITAL DISORDER OF REPRODUCTIVE SYSTEM.
FEMALES HAVING ANY DISEASES LIKE HIV, TUBERCULOSIS, INFECTIOUS DISEASE
MALE INFERTILE PATIENTS 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
CORREALTION OF SHARONI VISTARA (HIP CIRCUMFERENCE) AND BODY ADEPOSITY INDEX WITH STRI BANDHYATAVA WILL BE STABLISHED.  O DAY
1 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
CORRELATION OF SHARONI VISTARA (HIP CIRCUMFERENCE) AND BODY ADEPOSITY INDEX WITH STRI BANDHYATAVA WILL BE STABLISHED.  0 DAY- ASSESSMENT OF SUBJECT
1 DAY- EXAMINATION OF SUBJECT
2 DAY- MEASUREMENTS 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/06/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Meda dhatu (adipose tissue) is one of the seven Dhatus described in Ayurveda. When Meda increases in body it accumulates more at specific sites of body like Sphik (hip), Stana (breast), Udara (abdomen) etc. Atimedasvi (Obese) or Atisthoola is a person having pendulous appearance of Sphik (hip), Udara (abdomen) and Stana (breast), has unequal and abnormal distribution of Meda and reduced enthusiasm.Vitiation of Meda and Sleshma are responsible for Sthaulya.

Adiposity is a Latin term which is used for an excess unhealthy accumulation and storage of adipose tissue/ fat in the body. Conventionally, assessment of body fat (obesity) is determined through Body Mass Index (BMI) but an alternative parameter; Body Adiposity Index (BAI), defines the body mass that is made only of fat tissues in comparison to the former one that reflects the total body mass made up of bones, water content, fat and muscles of the body. BAI was purported to be a potentially rapid, inexpensive, and non-invasive assessment tool for use in clinical practice and is calculated from hip circumference and height of an individual (BAI = Hip circumference (cm) / Height (m)1.5- 18). Adiposity has physical, psychological and social consequences and is the prime risk factor for majority of diseases including cardiovascular diseases, stroke, hypertension, dyslipidemia, type 2 diabetes, osteoarthritis, respiratory problems & gynecological problems like abnormal menses and infertility.

Sushruta has well defined the measurement of different parts of the body in terms of Angula pramana. The topographical circumference of female Shroni (pelvic region/hip) is 24 Angula.

RESEARCH QUESTION

Is there any relation between Shroni vistara (hip circumference) and body Adiposity Index with Stri bandhyatava (female infertility)?

AIM-: To find out the relation between Shroni vistara and body adiposity index with Stri bandhyatva (Female Infertility)

 

OBJECTIVES

  • To measure the hip circumference
  • To measure the height
  • To calculate the BAI with the help of hip circumference and height by using formula BAI = Hip circumference (cm) / Height (m)1.5- 18
  • To measure Shroni Vistara in Angula praman.
  • To measure the linear distance between the most lateral point of proximal IP joint of index finger to most medial point of distal IP joint of little finger.

MATERIALS AND METHODS OF STUDY-

Study design – Cross-sectional analytical study

Study centre- PG Department of Rachana Sharira, OPD and IPD of CBPACS

Duration of study - 06 months.

Methodology-

Literary study: The effect of excess deposition of adipose tissue on the female reproductive system especially infertility will be explored from the reference books of Ayurveda and modern science.

Observational study:

  1. Two groups, Group A; infertile females of reproductive age and Group B; pregnant females of first trimester will be formed and 35 females in each group will be registered in the study from the hospital of CBPACS.
  2. Height of all the study participants will be measured by stadiometer as per SOP (Annexure-1).
  3. Hip circumference of all the study participants will be measured by measuring tape as per SOP (Annexure-2).
  4. The linear distance between most lateral point of proximal IP joint of index finger of right hand and most medial point of distal IP joint of little finger of right hand will be measured by digital Vernier calliper as per SOP (Annexure-3). This distance will be divided by four to attain the value of one Angula.

S. No

Group

Shroni Vistara (hip circumference in Angula)

Body adiposity index

1

Group A

 

 

2

Group B

 

 

 

Sample size – 70

Prevalence of Stree vandhayta is estimated 4.6%

With 4.6% of prevalence, 5% level of significance and 95% confidence interval [Daniel Formula]

n = Z2 p (1-p)/d2

n- Sample size, Z- confidence interval, p- prevalence, d- level of significance.

Z-1.96, p- 4.6%, d-5% (0.05)

n= 1.96ËŸ1.96ËŸ0.046 (1-0.046)/0.05ËŸ0.05= 67.30

⸫ Sample size = 68 patients

 

Inclusion criteria

  • Female Infertile subjects of age group 20 – 40 yrs in group A
  • Both primary and secondary infertile female.
  • Pregnant females of First trimester of age group 20-40 yrs in group B
  • Females who are ready to give consent for the study.

 

Exclusion criteria –

  • Females having any diseases like HIV, Tuberculosis, Infectious disease etc.
  • females having any congenital disorder of reproductive system.
  • females having any structural deformity related to reproductive system and hip region.
  • Male infertile partner.

 



 


 


 
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