| CTRI Number |
CTRI/2024/08/072773 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Hypothyroidism in Ayurvedic intervention |
|
Scientific Title of Study
|
A clinical study on hypothyroidism and its management with hamsapadiadi kashayam |
| 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 Sinsha A S |
| Designation |
PG Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidhyalaya Puri |
| Address |
Gopabandhu Ayurveda Mahavidhyalaya
Department of Kayachikitsa
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
8943081764 |
| Fax |
|
| Email |
sinshasalam9419@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sudarsan Behera |
| Designation |
Professor |
| Affiliation |
Gopabandhu Ayurveda Mahavidhyalaya VIP Road Puri |
| Address |
Former Principal
Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidhyalaya VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9437199477 |
| Fax |
|
| Email |
drsudarsanb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sudarsan Behera |
| Designation |
Professor |
| Affiliation |
Gopabandhu Ayurveda Mahavidhyalaya VIP Road Puri |
| Address |
Former Principal
Department of Kayachikitsa Gopabandhu Ayurveda Mahavidhyalaya VIP Road
Puri
ORISSA
752002
India |
| Phone |
9437199477 |
| Fax |
|
| Email |
drsudarsanb@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of PG Department of Kayachikitsa Gopabandhu Ayurveda Mahavidhyalaya VIP Road Puri Odisha, 752002 India |
|
|
Primary Sponsor
|
| Name |
Dr Sinsha AS |
| Address |
PG Department of Kayachikitsa Gopabandhu Ayurveda Mahavidhyalaya VIP Road Puri |
| 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 Sinsha AS |
Gopabandhu Ayurveda Mahavidhyalaya and Hospital |
OPD and IPD of PG Department of Kayachikitsa
Gopabandhu Ayurveda Mahavidhyalaya and Hospital VIP Road Puri Odisha
Puri
ORISSA |
8943081764
sinshasalam9419@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidhyalaya and Hospital Puri |
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 | Classical | | (1) Medicine Name: Hamsapadiadi kashayam, Reference: Vaidyamanorama Pratisyaya prakaranam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Levothyroxine | Levothyroxine 1.6 microgram per kilogram of body weight per day for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical signs and symptoms of hypothyroidism |
|
| ExclusionCriteria |
| Details |
Patient aged below 16 years and above 60 years.
Serum TSH level above 100 mIU/L
Patients having diabetes mellitus, hypertension, cardiovascular disease
Malignancy and Tuberculosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce signs and symptoms of hypothyroidism in patients |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To normalize serum TSH level in patients |
3 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 a single blind randomized controlled trial of 3 months duration to compare efficacy of Hamsapadiadi kashayam and levothyroxine in patients suffering from hypothyroidism. The primary outcome is to prevent hypothyroidism in patients within 3 months and the secondary outcome is to normalize serum TSH levels in patients. |