| CTRI Number |
CTRI/2024/11/077101 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [SUPPLEMENT] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Coenzyme Q10 on Insulin Resistance in Polycystic ovary syndrome patients
|
|
Scientific Title of Study
|
A prospective randomized open label study to evaluate effect of Coenzyme Q10 as an add-on to standard treatment in Insulin Resistant Polycystic ovary syndrome
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PCOS-01-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagur Sharone Grace |
| Designation |
Senior Resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
flat no 412, srilaxmi plaza, jafar ali bagh, somajiguda, Hyderabad
Hyderabad TELANGANA 500082 India |
| Phone |
9885421147 |
| Fax |
|
| Email |
nagursharongrace@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr P Usha rani |
| Designation |
Senior Professor and HOD |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
dept of clinical pharmacology and therapeutics, Nizams Institute of Medical Sciences
Hyderabad TELANGANA 500082 India |
| Phone |
984957414 |
| Fax |
|
| Email |
ushapingali@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr P Usha rani |
| Designation |
Senior Professor and HOD |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
dept of clinical pharmacology and therapeutics, Nizams Institute of Medical Sciences
Hyderabad TELANGANA 500082 India |
| Phone |
984957414 |
| Fax |
|
| Email |
ushapingali@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nagur Sharone Grace |
| Address |
Department of Clinical Pharmacology and Therapeutics Nizams Institute of Medical Sciences Pujagutta Hyderabad |
| Type of Sponsor |
Other [self] |
|
|
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 |
| NAGUR SHARONE GRACE |
Nizams Institute of Medical Sciences |
Department of clinical pharmacology, 2nd floor, NIMS, HYDERABAD Hyderabad TELANGANA |
9885421147
nagursharongrace@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N914||Secondary oligomenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coenzyme Q 10 |
Cap.Coenzyme Q10 200mg once daily after breakfast - intervention |
| Comparator Agent |
placebo |
matching placebo capsules - comparator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
newly diagnosed PCOS as per modified rotterdam criteria |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women, Subjects with type 1 or 2 Diabetes, Subjects who are on Metformin and/or COC pills for past 3 months, Subjects with history of hypo/hyperthyroidism, 9. Any medical condition or comorbidities, which in the clinician opinion could affect the safety and wellbeing of subjects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HOMA-IR between the groups |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in FBS, PPBS, HbA1c between the groups, within the group; Change in MDA between the groups, within the group; Incidence of adverse events with the study drug
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| 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 Applicable |
| 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
|
The study will be conducted in the
Department of Clinical Pharmacology & Therapeutics and Department of Obstetrics
& Gynaecology, after approval from the NIMS Institutional Ethics Committee.
Study will be conducted as per the principles laid down by the declaration of
Helsinki and in accordance with the ICH-Good Clinical Practice guidelines. The
study will be registered in CTRI. The study subjects diagnosed with PCOS as per
Modified Rotterdam criteria
will be given subject information sheet, study procedure will be explained and written
Informed Consent will be obtained.
At
screening (Visit-1), demography data, detailed medical
history, treatment history, general and systemic examination including vitals
will be recorded. 10 ml of blood will be collected for complete blood picture, fasting blood sugars (FBS) and fasting
insulin to calculate HOMA-IR, post-prandial blood sugars (PPBS), HbA1c, LFT,
RFT will be measured.
All the eligible subjects will be
asked to come to the study site in fasting state and enrolled into the study.
Any presenting complaints, General and systemic examination including vitals
will be recorded. 3
ml of blood sample will be collected for measurement of FBS,
PPBS,
lipid peroxidation marker-malondialdehyde (MDA)
at baseline(visit-2).
Subjects will be randomized into 2 groups using simple randomization method.
The random sequence will be generated using computer-generated random numbers
in allocation ratio 1:1.
Group A will
receive coenzyme Q10 once daily after breakfast, Group B will receive matching placebo once daily after
breakfast.
All the subjects will be on stable doses of standard medication Tab Metformin 1000mg per day + Tab. Ethinyl
estradiol 0.035mg and Tab. Cyproterone acetate 2mg.
Treatment duration will be for 12 weeks. Subjects will be asked to report to the study
site in fasting state for follow up at 4, 8, 12 weeks (visit 3,4,5
respectively).
At each follow up visit
(4,8,12 weeks) general and systemic examination
including vitals will be recorded.
At visit-3,4 (4,8 weeks) 3 ml of blood will be collected for estimation
of FBS, PPBS, MDA. At
the end of the study, visit-5 (12 weeks) 13 ml of blood will be collected to
assess CBP, LFT, RFT, FBS, PPBS, fasting insulin,
HbA1c, MDA.
HOMA-IR will be
calculated using formula, HOMA-IR = fasting [glucose
(nmol/L) X insulin (µU/mL)/22.5]. The levels of MDA will be
estimated by spectrophotometer. Compliance to study medications will be checked
by using pill count method at every visit. Any Adverse drug events will be recorded
in Case Record Form. |