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CTRI Number  CTRI/2013/08/003917 [Registered on: 23/08/2013] Trial Registered Retrospectively
Last Modified On: 23/08/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Hypothyroidism and its management with Ayurveda 
Scientific Title of Study   A Clinical Study On the Role of Vamana and Virechana in the management of Hypothyroidism with Punarnava Amruta Guggulu 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRATIKSHA PATERIYA 
Designation  PG Scholar Department of Panchkarma 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda  
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar JAMNAGAR GUJRAT
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India 
Phone  9601916926  
Fax    
Email  drpratikshaayu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof M S Baghel 
Designation  Director of Institute for Post Graduate Teaching and Research Ayurveda 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat  
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurveda University Jamnagar JAMNAGAR GUJARAT
Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurveda University Jamnagar JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India 
Phone  9427207964  
Fax    
Email  baghelayu@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anup B Thakar 
Designation  Associate Professor and HOD of Panchkarma Department  
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat  
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurveda University Jamnagar JAMNAGAR GUJARAT
Institute for Post Graduate Teaching and Research in Ayurveda Gujrat Ayurveda University Jamnagar JAMNAGAR GUJARAT
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Gujarat Ayurveda University 
 
Primary Sponsor  
Name  Institute for Post GraduateTeaching and Reseach in Ayurveda Gujarat Ayurveda University Jamnagar  
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar 361008 
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 pratiksha pateriya  Institute for Post Graduate Teaching and Research in Ayurveda   Department of Panchkarma OPD No 20 Jamnagar Gujarat 361008
Jamnagar
GUJARAT 		 9601916926

drpratikshaayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar 361008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HYPOTHYROIDISM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Vamana karma followed by punaranava amruta guggulu   Vamana karma with madanphalapippali churna 10gram vacha churna 5gram saidhava 10gram Madhu 50ml for 1 day followed by punaranava amruta guggulu 500mg 2 tablets thrice in a day for 45 days  
Intervention  Group B Virechana karma followed by punaranava amruta guggulu  Virechana karma with Trikatu churna 2gram Triphala churna 5gram Danti churna 10gram Trivritta churna 10gram Chitraka churna 1gram Snuhi kshira 10ml Gudodaka 80ml for 1 day followed by punaranava amruta guggulu 500mg 2 tablets thrice in a day for 45 days  
Comparator Agent  Group C Controlled drug Levothyroxine sodium  Dose as recommended by modern physician empty stomach in morning with water for 45 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with clinical features of Hypothyroidism namely increase level of serum TSH decrease level of serum T3 serum T4 irregular menstruation weakness fatigue weight gain hair fall constipation puffiness of face bilateral peripheral edema dry and coarse skin palpitation cold intolerance lethargy  
 
ExclusionCriteria 
Details  Patients with Ischemic heart diseases Uncontrolled hypertension Myocardial infarction Cardiovascular event Cardiac arrhythmia Pregnancy Active malignant disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The efficacy of treatment will be assessed on the basis of relief in signs and symptoms Evaluation of BIOCHEMICAL parameters such as serum TSH serum T3 and T4 in all groups with Hematological Urine routine and microscopic examination before and after treatment  60 Days in two interventional group A B and 45 Days in Controle group 
 
Secondary Outcome  
Outcome  TimePoints 
Exacerbation in signs and symptoms  4 Weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 1/ Phase 2 
Date of First Enrollment (India)   05/02/2013 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The present study is designed with the aims to study to evaluate the efficacy of Vamana karma in the management of Hypothyroidism, to study to evaluate the efficacy of Virechana karma in the management of Hypothyroidism after this as shamana drug PUNARANAVA AMRUTA GUGGULU in both groups and group C is controle with tablet Levothyroxine sodium

IN GROUP A VAMANA KARMA  

  Deepan pachana                           Trikatu churna            2g TDS with luke warm water         3-7days

                          Snehpan                                         Go ghrita                     as per Koshtha                                  3-7days
                             
                          Abhyanga and Swedana             Bala oil                         2 times a day                                     1day

                          vamana yoga(1day)                      Madanphalapippali   6-10g

                                                                                   Vacha  churna             2-5g
                                                                                   
                                                                                   Saidhava                      5-10g
                                                                                    
                                                                                   Honey                           50ml

                                                                                        Yastimadhu phant     2-3 Liter

                samsarjana karma                               Diet (as per shuddhi) 3-7days


IN GROUP B VIRECHANA KARMA       

 Deepan pachana(as

 Snehpana(as above)

                                                                            Abhyanga Swedana               Bala oil                                      3days

                                                     Virechana yoga(1 day)                        Trikatu churna         2g

                                                                                                                         Triphala churna      5g

                                                                                                                         Danti churna           10g

                                                                                                                         Trivritta churna        10g

                                                                                                                         Chitraka churna      1g

                                                                                                                         Snuhikshira             10ml

                                                                                                                         Gudodaka                40-80ml 

                               Samsarjana karma (as per shuddhi)                                                                                            3-7 days

Internal Shamana yoga    :Punaranava amruta guggulu                    1g tds(2 tablets each 500mg)     ANUPAN:Luke warm water          45 days


GROUP C :   Standered controle        Tab Levothyroxine sodium   dose :as per  physician prescribe    45 days




CRITERIYA FOR ASSESSMENT:
  
The efficacy of treatment will be assessed on the basis of relief in signs and symptoms

On the basis of changes in the laboratory investigation

Status of Dosha,Dushya and Agni will be assessed before after treatment


FOLLOW UP:

Follow up will be done for four weeks after the complition of treatment to see the long standing effect of the treatment.

Patients will be redirected to regular OPD treatment after the stipulated time of research work.  
 



                 


 
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