| CTRI Number |
CTRI/2025/03/082554 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Evaluate The Effectiveness Of Vibhitaki Churna In Treating Primary Hypothyroidism |
|
Scientific Title of Study
|
A RANDOMIZED OPEN-LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIBHITAKI CHURNA IN MANAGEMENT OF SUBCLINICAL 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 Mali Shruti Yuvraj |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD NO.5 Dept of Pg studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakpura Road Udayapura PO OB Chudahalli
Bangalore
560082
Karnataka
Bangalore KARNATAKA 560082 India |
| Phone |
9552656789 |
| Fax |
|
| Email |
shrutimali789@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic science and Research Hospital, Bangalore |
| Address |
Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakpura Road Udayapura PO OB Chudahalli
Bangalore
560082
Karnataka
Bangalore KARNATAKA 560082 India |
| Phone |
9844812331 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic science and Research Hospital, Bangalore |
| Address |
Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakpura Road Udayapura PO OB Chudahalli
Bangalore
560082
Karnataka
Bangalore KARNATAKA 560082 India |
| Phone |
9844812331 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital 21st KM, Kanakapura Road,Udayapura Post OB Chudahalli, Bangloare Karnataka 560082, India. |
|
|
Primary Sponsor
|
| Name |
Dr Mali Shruti Yuvraj |
| Address |
Dept of PG Studies in Kayachikitsa,
Sri Sri College of Ayurvedic science and Research 21stKm Kanakpura Road, Udaypura Post, Bangalore.
560082
India |
| 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 Mali Shruti Yuvraj |
Sri Sri College of Ayurvedic Science and Research Hospital |
OPD N0 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Road Udayapura PO, OB Chudahalli Bangalore, Karnataka 560082, India. Bangalore KARNATAKA |
9552656789 - shrutimali789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vibhitaki Churna , Reference: Kaiyadeva Nighantuh Aushadhivarga. Verse 244. 2017;48., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - Warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shadushana Churna, Reference: Bhavprakash Nighantu of Shri Bhavamishra; Haritakayadi , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Serum TSH level 4.2mIU/ml to 9.9mIU/ml and Normal serum T3,T4 levels
2. Subjects willing to participate with written informed consent, conveyed in language subject can understand |
|
| ExclusionCriteria |
| Details |
1. Subjects who have undergone any type of thyroid surgery.
2. Subjects who are on Hormone Replacement Therapy.
3. Subjects with uncontrolled hypertension and diabetes mellitus.
4.Subjects with Coronary artery diesease.
5. Subjects with Congenital, Autoimmune, and Secondary hypothyroidism.
6. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Significant decrease in serum TSH level.
|
0th day- Pretest assessment of subjective and objective parameters
15th day - assessment during trial period – subjective parameters
30th day - Post test assessment - subjective and objective parameters
45th day – Follow up assessment – subjective parameters
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To conduct a detailed literary review of Subclinical Hypothyroidism.
To record & report any adverse effect during the study period.
|
0th day, 2nd , 4th , 6th week |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0" 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
|
Hypothyroidism is a common endocrinological disease affecting the population worldwide. The annual risk of developing clinical Hypothyroidism is ~4%. The global prevalence of hypothyroidism is about 5-10% in women and 0-1% in men. The prevalence of Hypothyroidism in an epidemiological study in eight cities of India is 10.95%. Hypothyroidism is not a single disease entity but involves multiple systems in the pathogenesis. In the initial stages, symptoms seem to be vague and are often missed to diagnose. Instead, they are treated for PCOD, Infertility, Hyperlipidemia, Depression, etc. The condition of the patient worsens later on by affecting multiple systems. Hence hypothyroidism is an important public health issue.Subclinical Hypothyroidism refers to biochemical evidence of thyroid hormone deficiency in patients who have few or no apparent clinical features of hypothyroidism.Hormone Replacement Therapy (Levothyroxine) is the only available treatment in contemporary medicine. It brings the value of TSH (Thyroid Stimulating hormone) and T4 (Thyroxine) to the normal range but increases in dosage, continuous medication makes the patient drug dependent till the end of life. The major risk of Levothyroxine therapy is over-replacement with anxiety, muscle wasting, osteoporosis, and atrial fibrillation as adverse effects.
Though there is no direct reference regarding nomenclature similar to hypothyroidism in Ayurveda, the condition can be diagnosed based on the clinical presentation. An Anukta vyadhi can be appropriately managed by understanding the pathogenesis in terms of Dosha, Dhatu, Mala, and Agni. Analyzing the above factors, according to the Ayurveda Principles, we can identify the vitiation of Kapha and Vata dosha along with Rasa, Mamsa, and Meda dhatu in manifesting Hypothyroidism. |