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 |
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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 |
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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 |
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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 |
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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
|
|
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 |
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Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
CBPACS IEC |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E65||Localized adiposity. Ayurveda Condition: VANDHYA, |
|
Intervention / Comparator Agent
|
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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 |
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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
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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: - 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.
- Height of all the study participants will be measured by stadiometer as per SOP (Annexure-1).
- Hip circumference of all the study participants will be measured by measuring tape as per SOP (Annexure-2).
- 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= 1.96˟1.96˟0.046 (1-0.046)/0.05˟0.05= 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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