| CTRI Number |
CTRI/2022/10/046836 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of ayurvedic drug TNF34 tablets in patients with clinical and subclinical hypothyroidism |
|
Scientific Title of Study
|
A Double Blind Randomized Placebo Controlled Clinical Study to Evaluate the Efficacy
and Safety of TFN34 tablets for Individuals with Subclinical and Clinical Hypothyroidism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSNMeenakshi sundariMD |
| Designation |
Professor Dept of General Medicine |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre kattankulathur
SRM Medical College Hospital and Research Centre kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444249933 |
| Fax |
|
| Email |
dr.meenakshisundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSNMeenakshi sundariMD |
| Designation |
Professor Dept of General Medicine |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre kattankulathur
SRM Medical College Hospital and Research Centre kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444249933 |
| Fax |
|
| Email |
dr.meenakshisundari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BMothishwaran |
| Designation |
student |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre kattankulathur
SRM Medical College Hospital and Research Centre kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
drmothishwaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Private Limited Research and Development Centre
Apex Laboratories Ltd.
Registered Address :3RD Floor, Sidco Garment Complex
Guindy
Chennai
Chennai - 600032
Tamil Nadu - India |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Private Limited Research and Development Centre |
| Address |
B-59 Irrungattukottai SIPCOT
Chennai - 602105 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 S N MEENAKSHI SUNDARI |
SRM Medical College Hospital and Research Centre general medicine OPD ayurveda OPD |
SRM Medical College Hospital and Research Centre general medicine OPD ayurveda OPD
Kancheepuram
TAMIL NADU |
9444249933
dr.meenakshisundari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
placebo is given for another group as a comparator agent.2 tablets should be taken in the morning and night before food orally for 6 months duration.
tablet has no active ingredient( placebo) |
| Intervention |
TNF34 TABLETS |
2 tablets should be taken in the morning and night before food orally for 6 months duration.
tablet contains polyherbal formulations |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with TSH Value greater than or equal to 4.5
ï‚· Individual presenting with at least four of the symptoms like Fatigue, cold
intolerance, Constipation, Dry rough & pale skin, Weight gain, Puffiness of face,
Hoarseness, Muscle weakness, Muscle cramps and frequent muscle aches, Abnormal
menstrual cycle, Dry, coarse thinning of hair, Hair loss, Slowed heart rate,
Depression, Irritability, Impaired memory, Decreased libido.
ï‚· Subjects willing to sign informed consent and follow the study procedure.
ï‚· Has not participated in a similar investigation in the past four weeks.
|
|
| ExclusionCriteria |
| Details |
Subjects currently on levothyroxine, anti-thyroid drugs, amiodarone or lithium.
Subjects with any clinically significant and uncontrolled systemic illnesses
(including Gastrointestinal, Cardiac, Neurological, Respiratory, Immunological or
endocrinological disorder) as judged by the investigator, which can hamper the
participation of subjects in clinical study.
ï‚· Hospitalization for major illnesses/ elective surgery within 4 weeks
Clinical diagnosis of any psychiatric or psychological disorders rendering the subject
not to follow the study procedures.
Pregnant or lactating women or women of child bearing potential not willing to use
the established measures of of contraception. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical improvement in the overall health as assessed by clinical examination of signs and
symptoms such as Fatigue, cold intolerance, Puffiness of face, Hoarseness, Muscle weakness,
Hair loss, Slowed heart rate, Depression, Irritability, Impaired memory and the points
mentioned in questionnaire.
ï‚· Blood levels of FT3 levels, FT4 levels, TSH, T3 levels, T4 levels |
Clinical improvement in the overall health as assessed by clinical examination of signs and
symptoms in 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence to identify the AE and compliance to the study |
Incidence to identify the AE and compliance to the study in between 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
14/11/2022 |
| 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="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is A Double Blind, Randomized, and Placebo Controlled Clinical Study to Evaluate Efficacy and Safety of TFN34 tablets in Individuals with subclinical & clinical hypothyroidism. Subjects who have qualified screening and are willing to participate in the study will be called for the study. This will be a double blind placebo controlled study. In this study, 60 subjects randomized to two groups in 1:1 ratio, who fulfill the inclusion criteria, will be selected. As per computer generated randomization sequence, all the subjects will be advised to take 2 tablets of TFN34 tablets or Placebo twice daily before food for a period of 6 months. Allocations will be concealed using sealed envelopes. Outcome assessor is not blinded as only investigators and subjects are blinded in a double blind study. Dosage: 2 tablets of TFN34 Tablets or similar looking Placebo twice daily before food. |