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CTRI Number  CTRI/2024/12/078599 [Registered on: 26/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of Hingwashtak churna in the treatment of Hypothyroidism 
Scientific Title of Study   Single arm clinical study to assess the efficacy of Hingwashtak churna in the management of 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  Sayali Sanjay Supanekar 
Designation  PG Scholar 
Affiliation  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur 
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli

Sangli
MAHARASHTRA
415409
India 
Phone  7057254428  
Fax    
Email  sup_sayali@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonal Shah 
Designation  Professor 
Affiliation  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur 
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli

Sangli
MAHARASHTRA
415409
India 
Phone  7972759476  
Fax    
Email  drsonalshah2014@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonal Shah 
Designation  Professor 
Affiliation  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur 
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli

Sangli
MAHARASHTRA
415409
India 
Phone  7972759476  
Fax    
Email  drsonalshah2014@gmail.com  
 
Source of Monetary or Material Support  
Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research center Islampur 415409 
 
Primary Sponsor  
Name  Sayali Sanjay Supanekar 
Address  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli 
Type of Sponsor  Other [Self] 
 
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 Sayali Sanjay Supanekar  LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur  OPD No 1 Kayachikitsa Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur
Sangli
MAHARASHTRA 		 7057254428

sup_sayali@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee LRP Ayurvedic Medical College and Hospital and PCT and RC Approved   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Hingwashtak churna, Reference: Kaviraj Shree Ambikadattshastri, Bhaishjyaratnawali, Agnimandya Chikitsa Adhyaya, Chaukhamha Prakashan Varanasi, Chapter No. 10, Shlok no 59, page no 338., Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ghrut), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients irrespective of gender economic class caste religion.
2) Patients which are newly diagnosed with Hypothyroidism.
3) Patients with known case of Hypothyroidism without taking any synthetic thyroid hormone derivatives for atleast 3 months, having only signs and symptoms of Hypothyroidism will be taken.
4) Patients with higher TSH level i.e. Range of serum TSH is in between 5.5 μIU/ml to 20 μIU/ml.
5) Patient have fulfilling criteria such as
1 Cold intolerance 2 Hoarseness of voice
3 Loss of Appetite 4 Constipation
5 Sleepiness 6 Tiredness 7 Generalized aches
and pain 8 Muscle cramps
 
 
ExclusionCriteria 
Details 
1) Age below 18 year and about 60 year.
2) Systemic illness like TB. Patient suffering from goiter.
3) CNS disorder, neurological disorders etc.
4) Thyrotoxicosis, thyroidectomy and other endocrine disorder.
5) HIV, cardiac disorder, malignancy, renal failure, pregnant women and lactating women.
6) Surgery induced and drug induced Hypothyroidism.
7) Patients with serum T.S.H. level i.e range of serum TSH is less than 5.5 μIU/ml and greater than 20 μIU/ml.
8) Patients on any synthetic thyroid hormone derivatives.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of Hingwashtak Churna in management of Hypothyroidism.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To study Hypothyroidism in detail.
2)To study Agni in detail.
3)To find any correlation between Hypothyroidism and Agni.
4)To study Hingwashtak Churna
in detail.
5)To study efficacy of Hingwashtak Churna in Hypothyroidism. 		 12 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/12/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In Ayurveda Agni is main factor which directly related with thermogenesis and metabolic activities in body. The main action of thyroid hormone is to act as a spark to start up body metabolism at cellular level. In Ayurveda it can be correlated with action of Agni, which brings about all the chemical reaction and transformation in the body. Agnimandya is one of the most common disorder of Agni that is hypofunctioning of Jatharagni which affect the Dhatwagni, due to this there is formation of “Ama” which leads diseased condition. The normal and abnormal function of thyroid gland and Agni are similar. Also the symptoms of hypothyroidism are similar to Vata, Kapha Vriddhi and Pitta Kshay, Ama, Agnimandya. 

Today people suffering with Hypothyroidism taking synthetic thyroid hormone derivatives which brings abnormal values of serum TSH and T4 to normal range but if there is increased dosage and continuous medication for years together gradually develops complaints of increase the appetite, insomnia, heart palpitations. The prevalence rate of Hypothyroidism  in India is 11%.5 Women’s are affected approximately six times more than men’s.

To carry out the therapeutic maneuver, formulation “Hingwashtak Churna” have been tried to have a check on the diseased condition. Most of the drugs in this formulation have Deepana, Pachana, Ushna etc. qualities which stimulates body metabolism.


 
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