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CTRI Number  CTRI/2024/10/076022 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   A study on infertility due to obesity & its management with diet and exercise. 
Scientific Title of Study   A study on impact of obesity in infertile womens & its association with diet and exercise 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Femina Zainab  
Designation  PG Scholar  
Affiliation  Govt Nizamia Tibbi college and General Hospital  
Address  Govt. Nizamia Tibbi college and General Hospital, Charminar,Hyderabad, Telangana.

Hyderabad
TELANGANA
500002
India 
Phone  8328237076  
Fax    
Email  junaiduddin04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Maqbool Hussain  
Designation  HOD Professor  
Affiliation  Govt. Nizamia Tibbi college and General Hospital 
Address  Govt. Nizamia Tibbi college and General Hospital, Charminar,Hyderabad, Telangana

Hyderabad
TELANGANA
500002
India 
Phone  9948679786  
Fax    
Email  maqboolahmar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Femina Zainab  
Designation  PG Scholar  
Affiliation  Govt. Nizamia Tibbi college and General Hospital 
Address  Govt. Nizamia Tibbi college and General Hospital, Charminar,Hyderabad, Telangana

Hyderabad
TELANGANA
500002
India 
Phone  8328237076  
Fax    
Email  junaiduddin04@gmail.com  
 
Source of Monetary or Material Support  
Govt. Nizamia Tibbi college charminar Hyderabad Telangana 500002 India  
 
Primary Sponsor  
Name  Govt Nizamia Tibbi college  
Address  Govt. Nizamia Tibbi college and General Hospital, Charminar,Hyderabad, Telangana 500002 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 
Dr Femina Zainab   Govt Nizamia Tibbi college and General Hospital   Room No. -8 (gync. OPD) Room No. - 102 (spm OPD)
Hyderabad
TELANGANA 
8328237076

junaiduddin04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt Nizamia Tibbi college Institutional Ethic Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N978||Female infertility of other origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diet & Excercise   Advising Diet Chart & Excercise Daily for 1 hour morning and Evening for the Patients with BMI above 24 for 3 Months  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients willing to take part in study
Subjects having BMI - 25 & above 
 
ExclusionCriteria 
Details  Patients who are not giving informed consent.
Patients below 18 & above 45 years of age.
Patients with cardiac diseases and severe co-morbidities.
Patients taking oral contraceptive pills.
Patients having any reproductive congenital anomalies or any pathological defects. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reducing BMI   0th Day 15th Day 30th Day 60th Day 90th Day  
 
Secondary Outcome  
Outcome  TimePoints 
Conception & Regularisation of periods.  90th Day. 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   08/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
TITLE OF THE TOPIC :A STUDY ON “ IMPACT OF OBESITY (SIMAN E MUFARAT) IN INFERTILE WOMEN (BANJPAN) AND IT’S ASSOCIATION WITH DIET AND EXERCISE” In Patients Attending out patient department of gynecology at Govt Nizamia General Hospital, Charminar, Hyderabad.
Brief RESUME OF THE INTENDED WORK
Need of the study :
PREVANLANCE –
• In An Article of 2022, According to studiesit has shown that more than 40%of females with menstrual abnormalities, infertility are obese or overweight.(4)
• In India, As per the article of 2021Among The Study Population, The Prevalence Of Primary Infertility was 63.48% & Secondary Infertilitywas 36.52%. Among 115 Infertile women,92 were Pre Obese & 23 were Obese. On An Average Duration of 2-3 years of infertility, primary infertility was more commonIn Pre obese Women ( 70.65% ) where As Secondary Infertility moreCommon in obese Women ( 65.22% ).(5)
• Another Study of 2023shows that Women having Anovulation related infertility is 30% Higher in obese women compared to normalWeight women. (6)
• Over Weight & obese women have higher level of A Hormone Called Leptin,which is produced in Fatty tissues, which can disrupt the hormonal Balance& Leads to reduced fertility. (3)
• The risk of Infertility has been shown to be three fold higher in obese Women than in non obese women. (3)
In the view of Above Facts, i would like to conduct a study on “Impact of Obesity in Infertile womens’s& it’s Association With Diet And Excercise”.
REVIEW OF LITERATURE :- UNANI SYSTEM
• Abu Bakr Mohammad bin zakariah razi in his book “kitaab -ul- hawi” describes that mostly obese women Find It difficult to conceive because of excessive matter in abdomen which causes pressure on the cervix, which does not allow semen to enter into the cervix so until women loses weight cannot conceive. (7)
• Hakeem Abdul mansoor-hasan khamri in his Book“ ghina mana” describes that mostly obesed women who cannot conceive it’s cause can be because of accumulation of fat in the layers of vulva which causes the narrowing of the uterine cervix so this women cannot conceive until they lose weight. (8)
• Hakeem gulam jeelani Khan in his book “maqzan-ul hikamat”described that obesity (Farbahi)can be a cause to infertility (banjpan). (9)
• Hakeem Waseem Ahmed Aazmi in his book “amraaz -e-niswaan” described that obesity ( Siman -e-mufarat )as the cause for Infertility (aqar). (12)
• Hakeem Abdul mansoor -hasan khamri in his “ ghina mana” describes that Obesity causess Tahammul ( Tolerance ) To Excercise & cause Excessive Food intake leading to indigestion. This kind of people get more Prone to major Disease. They dies Early If Not then get weakness because they have more Bulgam Than Blood in the body. If Obese Women’s Get Pregnant they may Suffer With Asqaat e Hamal ( Abortion ) (8)
• According to Allama najeeb Uddin Samar Khandithe author of The book “shara -e-asbaab”described that Obesity ( farbahi ) as a cause for Infertility (banjhpan )& said that In obese women, because of excessive fat in abdomen it creates pressure on uterus and cervix which can lead to Infertility. Also, described the treatment of obesity (Farbahi)with diet (Ghiza) , excercise(Riyazat)and diaphoresis(takmeed)..(13)
• Hakeem Ghulam jeelani Khan in his book “maqzan-ul- hikmat”describe that Obesity (motapa) can be treated by taking less fat and carbohydrate food with exercise but it should not cause exertion, also Said to include walking on daily basis. (9)
• According unani system of medicine the management of obesity is classified into two groups.
A .Non -pharmacological therapy
B. pharmacological therapy
Here we are discussing about non -pharmacological therapy
It can be of two types –
i. Ilaaj bil Ghiza (dieto therapy )
ii. Ilaaj bil tadabeer (regiminal therapy)
 Ilaaj bil Ghiza – avoid oily food ,intake of food is decreased only in terms of quality not in quantity ,the food should be less energetic but should give feeling of fullness to stomach .
Mizaaj of obese person Is barid because of (balghum) so in such condition the diet and
exercise which produce haar yabis mizaaj should be prescribed.
 Ilaaj bil tabadeer -this includes
 Takaan kizyadati (Exertion)
 Kasrate Riyazat (exercise)
 Tareekh(diaphoresis)
 Hamame yabis(dry bath)
Lifestyle modification ,diet and excercise are the corner stone of any weight loss program. (14)
MODERN THEORY
Infertility- infertility is defined as unable to conceive within 1 year of regular unprotected intercourse.
Classification:
1.Primary infertility – those who never conceived .
2.Secondary infertility- it indicates previous pregnancy but failure to conceive subsequently.(1)
Aetiology/causes of infertility-
Multiple factors are responsible for Infertility in women’s
 Systemic defect like age factor,BMI rate,smoking, alocoholetc.
 Sexual dysfunction like vaginismus ,dysparaunia.
 Endocrine dysfunction like amenorrhea, dub,PCOS, hypothyroidism,hyperprolactinemia , drugs like anti epileptic ,anti psychotic Etc. may lead to Anovulation.
 Pathological defect like vaginal or uterine or cervical or tubal ovarian or peritoneal disease/disorders.
From the above factors we are taking BMI rate (obesity) into our consideration
Obesity represents rapidly growing threat to health of the population which has detrimental affect on fertility by disrupting the neuro endocrinal and ovulatory function. (15)
Obesity –obesity is defined as an excess of adipose tissue that imparts health risk .(16)
It usually results from more energy intake and less energy expenditure. It is emerging as an epedemic in the modern era & thus leading to arise many questions on health of community. (2),(3).
Obesity is expressed in terms of body mass index.
                           BMI = weight In kgs / height in m2
Classification: according to BMI
                                  Normal range 18.50 - 24.99
                                  Overweight >25
 Pre obese 25 -29
 Obese class 1. 30 -34
 Obese class 2. 35-39
 Obese class 3. 40.00. (16)
In women, it can cause the overproduction of insulin, which may cause irregular ovulation. obesity, excess insulin production and the infertility condition known as polycystic ovarian syndrome (PCOS) it is associated with irregular menstrual cycles, anovulation (decreased or stopped ovulation), obesity and elevated levels of male hormones.
Thus, it is said that Obesity is a major health issue associated with infertility and many other co-morbid conditions. Studies show weight-loss is extremely valuable in the management of such patients, can enhance fertility, and lead to successful full term pregnancies. (10)
Hazards’/ complications of obesity:
 It’s a positive risk factor for HTN, DM,CAD,certain types of cancer,OA,hernia, varicose veins , infertility etc.(17)
 It’s affect on female reproductive health is like anovulatory infertility, Breast cancer , ovarianoruterine disorders ,PCOS, precocious, puberty etc. (18)
Management : Exercises which produce haar yabis mizaaj should be prescribed .Risk of obesity are largely reversible if identified and treated early. current lifestyle with labour saving devices , sedentary work and passive leisure activities have much lower energy requirements.
The Management plan will vary according to severity of the obesity and the associated risk factors and complications.(11) Preventive and control : weight control is defined as approaches to maintain weight within healthy range of BMI (18-24) throughout adulthood .
This can be achieved by
 Dietary changes
 Increase physical activity
Dietary changes:
The proportions of energy dense foods such as simple carbohydrate and fats should be reduced,the fibre content should be increased&Adequate levels of nutrients (essential) in low energy diet.
 The most basic consideration is that food energy intake should not be greater than what is necessary for energy expenditure.
 Strong motivation is required for patients for weight loss and to maintain ideal weight .
Increased physical activity –
It is important part of weight reducing program.regular physical exercise like walking,swimming,dancing are few exercises which can be helpful for reducing weight. (17)
Objectives of the study:
 To study the prevalence of “ obesity in infertile women’s “
 To show association of diet and exercise in infertile women’s.
 To provide knowledge related to diet and exercise and create awareness among Obese Infertile women’sto lose weight in order to enhance the fertility rate.
 To provide motivation regarding lifestyle changes.
MATERIAL AND METHODS
 Source of Data:- Patient Attending outpatient department of gynecology at Govt. Nizamia General Hospital, Charminar, Hyderabad, Telangana.
 Method of Collection of Data:- Data will be Collected by using a predesigned structured Questionnaire which contains open ended Question
 Inclusion Criteria:-
                                                         1.Age group :people of reproductive age i.e (18-45years )
                                                         2.Sex:female
                                                             3.Patient willing to take part in study
                                                             4.Religion : either
                                                             5.Subjects having BMI (25 and above )
 Exclusion Criteria:-
                                                 1. Patients who are not giving informed consent.
                                                  2.Patients below 18 and above 45 years of age.
                                    3.Patients with cardiac diseases and severe co- morbidities.
                                    4.Patients taking Oral contraceptive pills.
                                 5.Patients having Any Reproductive congenital anomalies or any pathological defects
 Study Design:-
• It is an Observational & Cross sectional study undertaken to assess and evaluate the effects of Obesity in infertile women’s.
 Sample Size:- All Available Patients attending at GNTC Hospital during the study of period
 Duration of Protocol:- 12 months
 Procedure of Study: It will be based on history taking , pre-design structured questionnaire,BMI Rate ,clinical features and interaction with patient
 Evaluation:- Data will be Analyzed statistically
Does the study require any investigations to be conducted on patients or Human Being or Animals  USG ofAbdomen and pelvis
 USG (Follicular Study)
 Lipidprofile
• Sr.cholesterol
• Sr. Triglycerides
• HDL
• LDL
 Liverfunctiontest
 Thyroidprofile
• T3
• T4
• TSH
Has Ethical clearance been obtained from your institution in case of 7.3

List of references: Bibliography
1.Dutta, D C , and HiralalKonar. DC Dutta’s Textbook of Gynecology : Including Contraception. 7th ed., New Delhi, Jaypee Brothers Medical Publishers (P) Ltd, 2014, pp.191-197.
2.P.Dounde, Dr.pranali , and Dr.PrasadP.Dounde. “Impact of Obesity on the Treatment of Infertility .” Medical Journal of Pharmaceutical Research , vol. 8, no. 5, 30 Feb. 2019, pp. 854–859, https://doi.org/10.20959/wjpr20195-14676.
3.Silvestris, Erica, et al. “Obesity as a Distributor of the Female Fertility .” Bio Med Central , 9 Mar. 2018, doi.org/10.1186/s12958-018-0336-z, https://doi.org/10.1186/s12958-018-0336-z.
4.Al-yasiry, RababZahir, et al. “How Obesity Affects Female Fertility.” Medical Journal of Babylon, vol. 19, no. 2, 2022, pp. 111–114, https://doi.org/10.4103/mjbl.mjbl_8_22. Accessed 17 Sept. 2022.
5.Dhandapani, Keerthana, et al. “Prevalence and Causes of Infertility in Overweight & Obese Women in a Tertiary Care Hospital Setup in Manglore .” J.Evid Based Med Health C2021, vol. 8, no. 29, 19 July 2021, pp. 2656–2660, https://doi.org/10.18410/jebmh/2021/489.
6.Mandal, Ananya. Obesity and Infertility - News Medical. 16 Aug. 2023, www.news-medical.net/health/Obesity-and-Infertility.aspx. Accessed 7 Sept. 2023.
7.Razi Z. Kitab al Hawi. Vol. 9. New Delhi: CCRUM; 2004, pp.71 – 74.
8.Qamari A. Ghina muna (translation - minhajulilaj). New Delhi: CCRUM; 2008, pp. 391 – 401&385-386.
9.Jeelani H gulam . Makhzanul hikmat. Vol. 2. New Delhi: Ejaz publication, pp. 1077 – 1078.
10.Sparks , Karen, et al. “Link between Infertility and Obesity .” Honor Health , p. E.
11.19.Britton, Robert, et al. Davidson’s Principles and Practice of Medicine. 23rd ed., Edinburgh, Elsevier, 2018, pp. 698 – 704.
12.Aazmi, Waseem Ahmed . Amraaz E Niswaa. New Delhi , Hakeem Waseem Ahmed Aazmi , 1991, pp. 314–328.
13.Samarqandi A najeebuddin. SharahAsbab. New delhi : Idara e kitab us shifa ; 2014, pp. 11 – 115.
14.K, Tabassum, et al. “Siman Mufrat (Obesity) a Lifestyle Disease and Its Impact on Women’s Health–Revention and Herbal Management.” Women’s Health, vol. 8, no. 5, 2019, pp. 291–297, https://doi.org/10.15406/mojwh.2019.08.00252. Accessed 19 Feb. 2021.
15.C.S Dawn. Textbook of Gynaecology, Contraception and Demography . 14th ed., Kolkata , 2003, pp. 103–109.
16.Khan, Saba, et al. “Efficiency of Unani Formulation in Infertility among Obese Women: A Clinical Study .” Research Gate, vol. 3, no. 4, Apr. 2017, pp. 125–133.
17.K Park. Park’s Textbook of Preventive and Social Medicine. 24th ed., India, Bhanot Publishers, 2017, pp. 415- 419.
18.Sunesh Kumar, et al. Shaw’s Textbook of Gynaecology. 17th ed., New Delhi, Elsevier India, 2018, pp. 542- 545.

 
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