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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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.

 
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