| CTRI Number |
CTRI/2025/11/096941 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding of Ayurvedic pulse parameters and dosha conditions in thyroid disorders |
|
Scientific Title of Study
|
Analytical study of Nadi parameters and dosha vaishamyata in thyroid disorders |
| 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 Paul Atul Ranjit |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Roga nidana KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9860060121 |
| Fax |
|
| Email |
paulatul68ap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula K |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Roga nidana KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844946360 |
| Fax |
|
| Email |
nidan1819@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula K |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Roga nidana KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844946360 |
| Fax |
|
| Email |
nidan1819@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Paul Atul Ranjit |
| Address |
Department of Roga nidana KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Paul Atul Ranjit |
Shri B M Kankanwadi Ayurveda Mahavidyalaya |
OPD no 3 Vishuddha ayurvedic endocrine centre Shahapur Belagavi
Belgaum
KARNATAKA |
9860060121
paulatul68ap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for research on human subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital shahapur Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E078||Other specified disorders of thyroid. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient having clinical features of thyroid disorder
Patient with serum TSH less than 0.4 mIU/L
Patient with serum TSH more than 4.5 mIU/L |
|
| ExclusionCriteria |
| Details |
Patients on any medication related to thyroid disorder
Patients with other systemic disorder like IBS Carcinoma infectious disease like TB and AIDS autoimmune disease like SLE RA
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is significant association between Dosha vaishamyata and nadi parameters in thyroid disorder |
30 minutes to 1 hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
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)
|
15/12/2025 |
| 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
|
Thyroid
disorders are the most common disorders we see in today’s world The function of
the thyroid gland under normal conditions is to maintain body metabolism This
action is carried out by the hormones produced by the thyroid gland The failure
of these hormones to maintain a regular metabolic rate in the body has two most
common conditions either: hypothyroidism and hyperthyroidism Prevalence of
hypothyroidism in india is 10.95% and prevalence of hyperthyroidism is 0.67% to
1.27% In hypothyroidism pulse rate is reduced and In hyperthyroidism there is tachycardia
The significance of Nadi Pareeksha is well understood and effectively
used by ayurveda practitioners for assessing tridoshas and various
physiological and pathological status of the patients As per classical texts the qualities or
properties of pulse such as nadi gati , nadi vega, nadi sthiratva, nadi kathinyata play a major role as
parameters of nadi pareeksha So in this study an
attempt is made for the critical analysis of nadi parameters in thyroid
disorders |