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CTRI Number  CTRI/2024/04/066435 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to assess the effectiveness and safety of Combination of Omega-3 Fatty Acids and Vitamin E versus Combined Oral Contraceptive Pills in Polycystic Ovarian Syndrome 
Scientific Title of Study   A Study of the Efficacy and Safety of Combination of Omega-3 Fatty Acids and Vitamin E versus Combined Oral Contraceptive Pills in Polycystic Ovarian Syndrome 
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 Jyoti Kaushal 
Designation  Senior Professor and Head of Department 
Affiliation  Pandit B. D. Sharma, PGIMS, Rohtak 
Address  3rd Floor, Department of Pharmacology, PGIMS, Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  9896149454  
Fax    
Email  jyotikaushal65@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Babita Narang 
Designation  Post Graduate 
Affiliation  Pandit B. D. Sharma, PGIMS, Rohtak 
Address  3rd Floor, Department of Pharmacology, PGIMS, Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  8469431222  
Fax    
Email  narangbabita8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Babita Narang 
Designation  Post Graduate 
Affiliation  Pandit B. D. Sharma, PGIMS, Rohtak 
Address  3rd Floor, Department of Pharmacology, PGIMS, Rohtak Haryana

Rohtak
HARYANA
124001
India 
Phone  8469431222  
Fax    
Email  narangbabita8@gmail.com  
 
Source of Monetary or Material Support  
Pandit B. D. Sharma, PGIMS, Rohtak 
 
Primary Sponsor  
Name  Pandit B. D. Sharma UHS Rohtak 
Address  Pandit B. D. Sharma UHS Rohtak Haryana 124001 
Type of Sponsor  Other [Other [Pandit B. D. Sharma UHS- Government]] 
 
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 Babita Narang  Pandit B. D. Sharma, PGIMS, Rohtak  First floor Department of Obstetrics and Gynaecology Ch. Ranbir Singh OPD Pandit BD Sharma PGIMS Rohtak, Haryana 124001 Rohtak HARYANA
Rohtak
HARYANA 
8469431222

narangbabita8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt BD Sharma PGIMS/UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ethinyl estradiol 30mcg + Levonorgestrel 150mcg  Tab Ethinyl estradiol 30mcg + Tab Levonorgestrel 150mcg will be given to other group of patients for 90 days. The enrolled patients will be assessed for hormonal, anthropometric and PCOSQ at baseline and 90 days 
Intervention  Omega-3 Fatty acids + Vitamin E   Cap. Omega-3 Fatty acids 1000mg + Cap. Vitamin E 400 IU will be given to 1 group of patients for 90 days. The enrolled patients will be assessed for hormonal, anthropometric and PCOSQ at baseline and 90 days. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Females of age group (15-45 years).
2. Subjects diagnosed with PCOS according to modified 2018 criteria (Rotterdam criteria): Presence of 2 out of 3 traits.
a. √ Presence of Hyperandrogenism (clinical and/or biochemical)
b. √ Oligo/Anovulation
c. √ PCOM (Polycystic ovarian morphology)- at least one ovary with
i ≥20 follicles per ovary in either ovary
ii ≥10 cm3 of ovarian volume
3. Patients willing to give written informed consent/assent.
 
 
ExclusionCriteria 
Details  1. Any history of Neoplastic disease.
2. Endocrinal disorders like Hyperprolactinemia, Hyper/ Hypo Thyroidism and Acromegaly.
3. Functional Hypothalamic amenorrhoea.
4. Already on PCOS treatment or have taken Vitamin supplements in the last 3 months.
5. Females who are either pregnant, willing to become pregnant or lactating.
6. Any Chronic Liver or renal disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Regularity of Menstrual cycle
-Decrease in hormonal parameters i.e. FSH, LH, FSH/LH ratio, Serum testosterone
-Decrease in modified FG score
-Decrease of other androgenic symptoms 
Baseline, 45days and 90days 
 
Secondary Outcome  
Outcome  TimePoints 
-Decrease in anthropometric parameters
-Decrease in metabolic parameters
-Change in Metabolic syndrome
-Change in quality of life 
Baseline, 45days and 90days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/05/2024 
Date of Study Completion (India) 06/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/05/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Polycystic ovarian syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age. Infertility, hirsutism, acne, obesity and menstruation disruption are some of the manifestations of this chronic and diverse illness. 

According to the WHO, Polycystic ovarian syndrome (PCOS) affects 8–13% of women who are of reproductive age. PCOS is a common condition among Indian women. The pooled prevalence of PCOS was 5.8% when using NIH criteria, compared to nearly 10% when utilizing Rotterdam’s and AES criteria.

In the modern era, it is acknowledged that mitochondria-generated oxidative stress and chronic inflammation, which are linked to hyperglycemia (HG), anovulation, hyperandrogenemia and insulin resistance (IR) are the primary causal factors of PCOS. Patients with PCOS have also been observed to have higher total oxidant status and greater IR.

Treatment for polycystic ovarian syndrome, a condition that affects a sizeable portion of women globally, is still centered on certain goals that may vary from woman to woman. Although causative therapy is preferable, it is not always possible because of our incomplete understanding of the syndrome’s pathophysiology.

Combined Oral Contraceptive Pills commonly prescribed for PCOS address two main symptoms i.e. irregular cycles and clinical signs of hyperandrogenism but having arterial hypertension, nausea, vomiting, headache, dermal lesions (acne, hirsutism), body weight gain, turgid breasts, leg cramps, vaginal staining or bleeding as their common side effects while the combination of Omega-3 Fatty Acids + Vitamin E has shown to provide good results in taking care of all domains i.e. endocrine, metabolic as well as the quality of life with minimal side effects.

A total of 60 patients will be enrolled and written informed consent will be taken from patients. Primary and secondary outcomes will be analyzed at baseline, 45 days and 90 days while we will monitor for any Adverse Drug Reactions (Safety Assessment) throughout the study.

The present study is therefore being taken to compare the efficacy and safety of combination of Omega-3 Fatty acids + Vitamin E with Combined Oral Contraceptive Pills in PCOS women. This study is ethically justified because the drugs; Combined Oral Contraceptives Pills, Vitamin E and Omega-3 Fatty Acids are already marketed and are in use individually for the treatment of PCOS symptoms.


 
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