| CTRI Number |
CTRI/2024/07/070144 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the Efficacy of Thyrocompound in the management of Subclinical Hypothyroidism. |
|
Scientific Title of Study
|
A Randomized controlled clinical Trial to study the efficacy of Thyrocompound in the management of Subclinical Hypothyroidism. |
| 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 Varsharani Arjun Chaudhari |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Department of Kayachikitsa,OPD No.2,Kamal nagar, Hirawadi, Panchavati, Nashik.
Nashik
MAHARASHTRA
420003
India |
| Phone |
7030787516 |
| Fax |
|
| Email |
varsharaniniphade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Popat V Jagtap |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Department of Kayachikitsa,OPD No.2,Kamal nagar, Hirawadi, Panchavati, Nashik.
Nashik
MAHARASHTRA
420003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Popat V Jagtap |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Department of Kayachikitsa,OPD No.2,Kamal nagar, Hirawadi, Panchavati, Nashik.
MAHARASHTRA
420003
India |
| Phone |
9822852144 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi,Panchavati, Nashik 420003
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Varsharani Arjun Chaudhari |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Department of Kayachikitsa,OPD No.2,Kamal nagar, Hirawadi, Panchavati, Nashik 420003
Maharashtra
India |
| 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 |
| Dr Varsharani Arjun Chaudhari |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Nashik. |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Department of Kayachikitsa, OPD No.2, Kamal nagar, Hirawadi, Panchavati, Nashik 420003
Maharashtra
India
Nashik
MAHARASHTRA |
7030787516
varsharaniniphade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Thyrocompound, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -sukhoshna jal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Levothyroxine | The prescribed individualized dose of tab Levothyroxine will be continued empty stomach only early in the morning for 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of grade 1 subclinical hypothyroidism having serum TSH level within range of 4.9 mL/L to 10 mL/L.
2.Patients having 3 clinical symptoms of subclinical hypothyroidism among following-
tiredness weakness lethargy dry skin and hair cold intolerance loss of hairs difficulty in concentration and poor memory weight gain with poor appetite constipation hoarseness of voice dypsonea menorrhagia puffy face hands and feet bradycardia |
|
| ExclusionCriteria |
| Details |
1. Grade 2 subclinical hypothyroidism serum TSH level more than 10 mL/L.
2. Primary hypothyroidism caused due to thyroidectomy radioactive Iodine Therapy for Graves disease or Nodular Goiter. Radio therapy for head and neck cancer.
3. Secondary hypothyroidism
4. Patients Having history of medications like Amiodarone, Interleukin -2 Kinase inhibitor and lithium
5. Patients undergoing any known hormonal therapy other than Levothyroxine
6. Patients suffering from chronic anemia
7. Co morbid patients like known case of HTN, DM, IHD, Angina , MI
8. Patients receiving anti retro viral therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect on Weight BMI Serum TSH Total Cholesterol LDL HDL Triglycerides
Tiredness weight gain in last 3 months hair loss
dryness of hair and skin constipation
puffiness of face
muscle weakness
difficulty in concentration |
at Baseline and
13 weeks of Trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Age, sex, economical Status and Prakruti of subjects will be evaluated as a secondary outcome |
at the end of 13 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2024 |
| 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="3"
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
|
This study is Open Randomized control parallel group trial , comparing efficacy of oral administration of Thyrocompound 1 gm per day two times after food and Tab. Levothyroxine continued as per the prescribed individualized dose empty stomach only early in the morning for 90 days in 100 patients with presentation of Subclinical Hypothyroidism , that will be conducted in Maharashtra, India. The primary outcome measures will be Weight, BMI, Serum TSH levels, LDL, HDL, Total Cholesterol at the basement of subject enrollment and 91 th day at the end of trial. |