| CTRI Number |
CTRI/2019/12/022587 [Registered on: 31/12/2019] Trial Registered Prospectively |
| Last Modified On: |
30/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Survey study to check out the factors involved in manifestation of Hypothyroidism as per Ayurveda |
|
Scientific Title of Study
|
A Cross sectional survey study to assess the dosha dushya in Hypothyroidism by applying Karya kaarana siddhanta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreenidhi Kalmath |
| Designation |
post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Ayurveda Samhita and Siddhanta
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9900492080 |
| Fax |
|
| Email |
kalmathshreenidhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan M |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Ayurveda Samhita and Siddhanta
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
8884849477 |
| Fax |
|
| Email |
ayurchetan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreenidhi Kalmath |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Dept Of Ayurveda Samhita and Siddhanta
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9900492080 |
| Fax |
|
| Email |
kalmathshreenidhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan 573201 Karnataka India |
| Type of Sponsor |
Private medical college |
|
|
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 Shreenidhi Kalmath |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Depatment of Ayurveda Samhita and Siddhanta OPD 5 BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA |
9900492080
kalmathshreenidhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Primary hypothyroidism.
Patients with sub clinical hypothyroidism.
Patients who are ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Patients who have under gone any type of thyroid surgery.
Patients suffering from systemic diseases like Ischemic Heart Disease, Diabetes mellitus, carcinomas etc.
Patients suffering from congenital hypothyroidism
Pregnancy and lactation
Rapid progressive case of myxedema
Hypothyroidism due to drug therapy and infiltrative diseases like sarcoidosis, scleroderma, haemochromatosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dosha dushya are involved in Hypothyroidism |
One time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dosha dushya are involved in Hypothyroidism |
One time study |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2020 |
| 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
|
it will be published in approved journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Cross sectional survey study to assess dosha dushya in hypothyroidism. Dosha dushya are causative factors which are responsible for disease manifestation. As direct reference for hypothyroidism is not obtained from ayurveda classics, fundamental principles are applied to analyse these aspects such as the causative factors, the dosha leading to the manifestation of the disease, sthana of origin, should be examined in order to expand the understanding of the disease. Such a study will aid in the further understanding of treatment. |