| CTRI Number |
CTRI/2019/03/018181 [Registered on: 20/03/2019] Trial Registered Prospectively |
| Last Modified On: |
29/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of efficacy and safety of Thyroxine Sodium in Indian Patients with Primary Hypothyroidism |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single Arm, Non-Comparative Study to Evaluate the Effectiveness and Safety of Thyroxine Sodium in Indian Patients with Primary Hypothyroidism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Faraz Farishta |
| Designation |
Consultant Endocrinologist |
| Affiliation |
F S Endocrine and diabetes center |
| Address |
F S Endocrine and diabetes center
Opposite Indo English High School,
Santosh Nagar,Hyderabad
Hyderabad
TELANGANA
500 059
India |
| Phone |
9966096550 |
| Fax |
|
| Email |
drfarazfarishta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faraz Farishta |
| Designation |
Consultant Endocrinologist |
| Affiliation |
F S Endocrine and diabetes center |
| Address |
F S Endocrine and diabetes center
Opposite Indo English High School,
Santosh Nagar,Hyderabad
Hyderabad
TELANGANA
500 059
India |
| Phone |
9966096550 |
| Fax |
|
| Email |
drfarazfarishta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Faraz Farishta |
| Designation |
Consultant Endocrinologist |
| Affiliation |
F S Endocrine and diabetes center |
| Address |
F S Endocrine and diabetes center
Opposite Indo English High School,
Santosh Nagar,Hyderabad
Hyderabad
TELANGANA
500 059
India |
| Phone |
9966096550 |
| Fax |
|
| Email |
drfarazfarishta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Faraz Farishta |
| Address |
F S Endocrine and diabetes center
Opposite Indo English High School,
Santosh Nagar, Hyderabad-500 059 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deep Dutta |
Cedar Superspeciality Clinics |
Flat-33, DDA MIG Flats (Pocket-1),
Netaji Subhash Society Phase-2,
Sector 13 Main Rd, Sector-13
Dwarka
South West
DELHI |
8920600220
deepdutta2000@yahoo.com |
| Dr Deepak Khandelwal |
Dr. Khandelwals Diabetes & Endocrinology Clinic |
GH1/1, Archana Apartments, Opposite Lal Market,
Paschim Vihar
North West
DELHI |
9968878561
khandelwalaiims@gmail.com |
| Dr Faraz Farishta |
F S Endocrine and Diabetes center |
Opposite Indo English High School,
Santosh Nagar, Hyderabad-500 059
Hyderabad
TELANGANA |
9966096550
drfarazfarishta@gmail.com |
| Dr Shital Karnawat |
Karnawat Speciality Clinic and Diagnostic Centre |
Near Rajiv Gandhi Bhavan, Third Floor, Suyojit Sankul,
Sharanpur Road, Sharanpur,
Nashik
Nashik
MAHARASHTRA |
8446353531
shitalkarnawatkem@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Thumbay Hospital, Hyderabad |
Approved |
| Institutional Ethics Committee, Thumbay Hospital, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Thyroxine Sodium tablets |
Thyroxine will be administered as a single daily dose, preferably one-half to one-hour before breakfast. Each patient will take an initial oral dose of 1.7mcg/kg daily for 45 days. The dose will be adjusted at follow-up visit 1 (45 days) and/or at follow-up visit 2 (90 days) based on the TSH level. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Treatment naïve patients newly diagnosed with primary hypothyroidism
2. Patient with TSH level >10 mIU/L
3. Patients with fT4 level < 0.8 ng/dl
4. Patients willing to participate in the study, sign the Informed Consent Form (ICF) and ready to comply with protocol requirements
|
|
| ExclusionCriteria |
| Details |
1. Patients with primary hypothyroidism who are already on treatment with thyroxine for more than a month
2. Pregnant and/or lactating women
3. Patients with any acute or chronic cardiac or any other systemic illness that in the opinion of the investigator does not justify the patient’s inclusion in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Number and percentage of patients with normalization in TSH & fT4 levels over a period of 180 days (6 months) |
Baseline (Day 0)
45 days
90 days
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of thyroxine sodium in improving Zulewski score at 45, 90 and 180 days, compared to baseline
2. To evaluate the pattern of dose modification of thyroxine sodium at 45 and 90 days
3. To determine compliance to treatment with thyroxine sodium in patients with primary hypothyroidism |
Baseline (Day 0)
45 days
90 days
180 days |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/03/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The results of this study are planned to be published in order to provide new information on efficacy and safety of Thyroxine Sodium in management of Primary Hypothyroidism, in Indian population. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, single center, open-label, non-comparative study designed to evaluate effectiveness and safety of Thyroxine Sodium in treatment naïve patients newly diagnosed with primary hypothyroidism. The study population will include treatment naïve patients with newly diagnosed primary hypothyroidism, with TSH level >10 mIU/L and fT4 level < 0.8 ng/dl; meeting inclusion and exclusion criteria, and ready to give informed consent for study participation. Selection of patients for the study will be totally at the discretion of investigators. At baseline severity of disease will be assessed using Zulewski scale score. Patients will be prescribed Thyroxine Sodium at a dose of 1.7mcg/kg daily for 45 days. The dose will be escalated or titrated, based on progress patient is making after receiving Thyroxine Sodium at Follow-up Visit 1 (45 days) and/or at follow-up visit 2 (90 days) based on the TSH level. All patients will be followed up to a period of 180 days, after enrollment into the study. |