| CTRI Number |
CTRI/2025/09/095053 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Rasa, Rakta, Mansa and Meda Dhatu in Hypothyroidism |
|
Scientific Title of Study
|
ASSESSMENT OF RASA, RAKTA, MAMSA AND MEDA DHATU 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 Renu Rawat |
| Designation |
P.G Scholar |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD & IPD no. 21, P.G Department of Rog Nidan Evum Vikriti Vigyan, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
07037049540 |
| Fax |
|
| Email |
renurawat303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Proffessor & HOD |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD & IPD no. 21,P.G Departmeant of Rog Nidan Evum Vikriti Vigyan, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456100745 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Rawat |
| Designation |
P.G Scholar |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
P.G Departmeant of Rog Nidan Evum Vikriti Vigyan, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
07037049540 |
| Fax |
|
| Email |
renurawat303@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Haridwar, Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus, UAU, 249401 |
| Address |
Rishikul Campus, UAU, Haridwar Pin Code- 249401 |
| 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 Renu Rawat |
Rishikul Ayurvedic College |
I.P.D & O.P.D No. 21 P.G Departmeant of Rog Nidan Evum Vikriti Vigyan, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL |
07037049540
renurawat303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E018||Other iodine-deficiency related thyroid disorders and allied conditions. Ayurveda Condition: DHATUVAISHAMYAM, (2) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: DHATUVAISHAMYAM, (3) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: DHATUVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 18-60 years of either sex.
Diagnosed patients of hypothyroidism on the basis of signs and symptoms with abnormal T3, T4 and TSH level.
TSH 0.5-5.0 mIU/L
T3-80-180 ng/dL
T4-5.0-12.0 µg/dL
|
|
| ExclusionCriteria |
| Details |
Patients of age below 18 or more than 60 years.
Patients having Grave’s disease, thyrotoxicity, and other endocrine chronic disease.
Pregnency
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reationship between the Dhatu (Rasa, rakta, Mamsa,Medo) Vaishamya in Hypothyroidism |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe Dhatu Kshaya Vridhi in Hypothyroidism |
1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/09/2025 |
| 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
|
This study will be done to observe the relationship between Dhatu (Rasa, Rakta, Mamsa, Meda) Vaishamya and Hypothyroidism.The patient fullfilling the incusion criteria will be taken in this study. After this, symtoms of the patient will be compared with the classical symtoms of Dhatu(Rasa, Rakta, Mamsa, Meda) Kshaya and Vridhi. On basis of the result a relationship will be established . It will help in understanding ayurvedic perspective of disease hence providing new line of ayurvedic treatment. |