| CTRI Number |
CTRI/2019/11/022113 [Registered on: 22/11/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diet history in PCOD |
|
Scientific Title of Study
|
Lifestyle and diet patterns of patients with poly cystic ovarian syndrome attending tertiary care hospital, Rajahmundry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murali K Krishna |
| Designation |
Asst. Professor |
| Affiliation |
GSL Medical College |
| Address |
No 11
Dept. of General Medicine
GSL General Hospital
Rajanagaram Mandal
Hukumpeta
East Godavari
ANDHRA PRADESH
533297
India |
| Phone |
9948860777 |
| Fax |
|
| Email |
murali8573@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Murali K Krishna |
| Designation |
Asst. Professor |
| Affiliation |
GSL Medical College |
| Address |
No 11
Dept. of General Medicine
GSL General Hospital
Rajanagaram Mandal
Hukumpeta
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
9948860777 |
| Fax |
|
| Email |
murali8573@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Murali K Krishna |
| Designation |
Asst. Professor |
| Affiliation |
GSL Medical College |
| Address |
No 11
Dept. of General Medicine
GSL General Hospital
Rajanagaram Mandal
Hukumpeta
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
9948860777 |
| Fax |
|
| Email |
murali8573@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ansari Nagar,
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GSL Medical College |
NH 16,
Laxmipuram,
Rajanagaram,
Rajamahendravaram,
E.G.Dt.
Andhra Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Murali Krishna K |
GSL Medical College |
No 11
Dept. of General Medicine
East Godavari
ANDHRA PRADESH |
9948860777
murali8573@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Females diagnosed with PCOS using rotterdam criteria. |
|
| ExclusionCriteria |
| Details |
Not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Etiological clue |
after analysis of results |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical profile |
by the end of the trial |
| Diet history and correlation with PCOS |
after analysis of results |
| lifestyle and risk of PCOS |
after analysis of results |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Polycystic ovary syndrome (PCOS) is a multifactorial disorder and different genetic, hormonal, and environmental etiology can contribute to its pathology (1). The diagnosis of PCOS in women is usually according to Rotterdam criteria, which is based on having at least two of three characteristics of oligo-ovulation/ anovulation, hyperandrogenism and polycystic ovaries using ultrasonographic images
(2). Many hypotheses about the pathophysiology of PCOS that have been explained so far, include: resistant to rupture of follicles due to shell thickness, ovarian hyperandrogenism, luteinizing hormone (LH) hypersecretion, hyperinsulinemia, and impaired ovarian follicular development due to increased follicular development blocker paracrine factors, such as anti-Müllerian hormone (AMH) (3). The causes of any of these abnormalities may be due to genetic factors that are commonly found in homozygous twins studies or due to metabolic, hormonal, nutritional or even toxic changes during embryonic development and in early stages of female gonad differentiation (4). But still, the exact origin of each abnormality is unclear. Several observations show that the interaction of several genetic factors and environmental factors are necessary for PCOS development.
References 1. De Leo V, Musacchio M, Cappelli V, Massaro M, Morgante G,
Petraglia F. Genetic, hormonal and metabolic aspects of PCOS:
an update. Reprod Biol Endocrinol 2016;14:38-54. 2. Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic
criteria and long-term health risks related to polycystic ovary
syndrome (PCOS). Hum Reprod 2004;19:41-47. 3. Fenichel P, Rougier C, Hieronimus S, Chevalier N. Which
origin for polycystic ovaries syndrome: Genetic, environmental
or both? Ann Endocrinol 2017;78:176-185. 4. Deligeoroglou E, Kouskouti C, Christopoulos P. The role of
genes in the polycystic ovary syndrome: predisposition and
mechanisms. Gynecol Endocrinol 2009;25:603-609. |