| 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
|
|
|
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
|
|
|
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.
|
|
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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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