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CTRI Number  CTRI/2024/03/063467 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Importance of Yogasana and Chitrakadi vati in Hypothyroidism. 
Scientific Title of Study   A clinical study on Combined effectiveness of Yoga Module and Chitrakadi vati in Hypothyroidism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhuvaneshwari 
Designation  PhD Scholar dept. of Swasthavritta 
Affiliation  SDM College of Ayurveda and Hospital Hassan 
Address  Dr Bhuvaneshwari, Department of Swasthavritta.SDM College of Ayurveda and Hospital, Tanneruhalli Hassan

Hassan
KARNATAKA
573201
India 
Phone  8123595928  
Fax    
Email  bgpatil33@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar 
Designation  Asso. Professor dept. of Swasthavritta 
Affiliation  SDM College of Ayurveda and Hospital Hassan 
Address  Dr Shivakumar, Department of Swasthavritta.SDM College of Ayurveda and Hospital, Tanneruhalli Hassan
Dr Shivakumar, Department of Swasthavritta.SDM College of Ayurveda and Hospital, Tanneruhalli Hassan
Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshivak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhuvaneshwari 
Designation  PhD Scholar dept. of Swasthavritta 
Affiliation  SDM College of Ayurveda and Hospital Hassan 
Address  Dr Bhuvaneshwari, Department of Swasthavritta.SDM College of Ayurveda and Hospital, Tanneruhalli Hassan

Hassan
KARNATAKA
573201
India 
Phone  8123595928  
Fax    
Email  bgpatil33@gmail.com  
 
Source of Monetary or Material Support  
OPD of Multicentric centers SDM College of Ayurveda and Hospital Hassan and BLDEAs AVS AMV hospital and Research center Vijayapur 
 
Primary Sponsor  
Name  Dr Bhuvaneshwari PhD Scholar 
Address  Dr Bhuvaneshwari PhD Scholar. Shri Dhramastahala Manjunatheshwara College of Ayurveda and Hassan 
Type of Sponsor  Other [Dr Bhuvaneshwari Patil] 
 
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 Bhuvaneshwari  SDM College of Ayurveda Hospital and Research Center Hassan.  Dr Bhuvaneshwari Dept of Swasthavritta SDM College of Ayurveda Hospital and Research Center Tanneruhalli Hassan.
Hassan
KARNATAKA 		 8123595928

bgpatil33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Chitrakadi Vati, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmProcedure-vyAyAmaH, व्यायामः (Procedure Reference: Patanjali Yoga Sutra, Procedure details: Prepared Yoga protocol- prayer, Shitilikarana vyayama ie Neck exercises, 1)Standing asana- arda chakrasana,ardakatichakrasana. 2)Sitting asana- Arda Ustrasana, Ustrasana 3)Prone postures- Bhujangasana, Dhanurasana 4)Supine Postures- Matsyasana, Halasana, Setubandasana and Sarvangasana 5) Pranayam - Nadishodana pranayam 6) Dhyana - Vishudda chakra mantra "HAM" chanting for 108 times and close with prayer. this protcol practice for 50min with each asana 5cycles for period of 3months)
3Intervention ArmDrugClassical(1) Medicine Name: Chitrakadi vati, Reference: Bhaisaja Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Patients are adviced to take Chitrakadi vati and Fallowed by Yogasana Protocol as per prepared for interval of 3minths
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects with TSH value between 5 -30 mUI /L
2.Subjects fulfilling the diagnostic criteria
3.Subjects who are freshly diagnosed as Hypothyroidism.
4.Known case of Hypothyroidism with or without medication
5.Subjects between the age of 20 to 60 years of either gender.
6.Subjects fit for regular practice of yogasana
7.Subjects who are ready to sign informed consent form.
 
 
ExclusionCriteria 
Details  1.Primary Hypothyroidism with elevated TSH & low serum thyroxine (T4) and triodothyronine (T3) (Hashimoto thyroiditis) & Post Radio Iodine Therapy Hypothyroidism&Post-operative Hypothyroidism.
2.Known subjects of Thyrotoxicosis, Congenital Anamolies, Myxedema, Secondary Hypothyroidism and its complications.
3.Subjects established withCardiac disorders, Hyper tension,Diabetes mellitus and Hyper acidity.
4.Hypothyroidism in pregnancy and lactating mother.
5.Known case ofNeoplasia, Toxic Goitre.
6.Known case of mental illness.
7.Any condition which investigator thinks may jeopardize the study

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in clinical features of Hypothyroidism like, reduced TSH level, weight gain etc  03 months 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in associated complaints like hairfall, Menustral disorders.  03months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   06/12/2024 
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   Not yet done. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  article

  6. For how long will this data be available start date provided 23-01-2026 and end date provided 23-01-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Diagnosed cases of 120 subjects fulfilling inclusion criteria will be selected for the study after subjecting them through clinical and lab examination as per the proforma prepared for the study irrespective of gender, age, and religion and made in to 3 groups 
Group A - Minimum of 40 diagnosed cases of Hypothyroidism will be selected and explained nature of study and taken written consent and adviced Yoga Module for 50min with each Asana 5 cycles for period of 90 days.
Group B - Minimum of 40 diagnosed cases of Hypothyroidism will be selected and explained regarding Nature of Study and taken written consent and administered Chitrakadi vati 250mg BD with potable water before meal for 90 days.
Group C- Minimum of 40 diagnosed cases of Hypothyroidism will be selected and explained regarding Nature of Study and taken written consent and adviced Yoga Module for 50 min with each asana 5 cycles along with Chitrakadi vati of 250mg BD administered for 90 days.
Medicines will be procured from SDM pharmacy college Udupi and designed Yoga protocol will be adviced and demonstrated and study will be conducted for period of 90 days.
Data will be collected and tabulated ,analysed using SPSS version 20 or using appropriate Statistical methods.

 
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