| CTRI Number |
CTRI/2025/01/079626 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate the Status of Nadi, Digestive Power, Bowel Habit, Mental status in patients suffering from Hypothyroidism |
|
Scientific Title of Study
|
Clinical Evaluation Of Nadi, Agni, Kostha, Sattva In 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 Giriyavvanavara Rangaswami |
| Designation |
MD Scholar |
| Affiliation |
Institute of Medical Sciences ,Banaras Hindu University ,Varanasi |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9353174676 |
| Fax |
|
| Email |
rangaswamirangu1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramanand Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7007882476 |
| Fax |
|
| Email |
ramanand@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramanand Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Medical Sciences ,Banaras Hindu University ,Varanasi |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7007882476 |
| Fax |
|
| Email |
ramanand@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005 Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Head of the Department Vikriti Vigyan |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221005, Uttar Pradesh, India. |
| Type of Sponsor |
Government 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 GIRIYAVVANAVARA RANGASWAMI |
Institute of Medical Sciences SSHospital |
Department of Endocrinology ,Institute of Medical Sciences Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH |
9353174676
rangaswamirangu1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient willing to participate
2.diagnosed patient of hypothyroidism (TSH more than 10 mU/l |
|
| ExclusionCriteria |
| Details |
1.patient below 18 years and above 60 years
2.patients undergoing for any other systemic illness
3.carcinoma of thyroid gland
4.patient are who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of etiological factors of hypothyroidism along with Sampriti Ghataka.
2. Assessment of Nadi Pariksha in hypothyroidism
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the association of Agni bala Types of Kostha & Sattwa bala with hypothyroidism |
One Year |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
06/02/2025 |
| 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="6"
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
|
77 Patients of Hypothyroidism will be selected, and their status of Nadi, Agni, Kosta, and Sattva will be examined through the Ayurvedic classical method as mentioned in the text. Agni, Kosta and Sattva will be assessed by a validated questionnaire. The data will be analyzed with appropriate statistical methods. |