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CTRI Number  CTRI/2023/07/054616 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Pippali Churna and Shad-dharana Churna in the management of Hypothyroidism 
Scientific Title of Study   An open labelled randomized comparative clinical trial of Pippali Churna and Shad-dharana 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  Snehalben Baria 
Designation  PG Scholar 
Affiliation  Government Akhandanand Ayurveda College and Hospital 
Address  OPD NO 4 Kayachikista Department Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  9825938166  
Fax    
Email  snehalbaria97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dipti S Purani 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Government Akhandanand Ayurveda College and Hospital 
Address  OPD NO 4 Kayachikista Department Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  9427794040  
Fax    
Email  diptipandya73@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dipti S Purani 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Government Akhandanand Ayurveda College and Hospital 
Address  OPD NO 4 Kayachikista Department Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat

Ahmadabad
GUJARAT
380001
India 
Phone  9427794040  
Fax    
Email  diptipandya73@yahoo.in  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurveda College and Hospital 
 
Primary Sponsor  
Name  Government Akhandanand Ayurveda College 
Address  OPD NO 4, Kayachikista Department,Government Akhandanand Ayurveda College, Bhadra ,Ahmedabad,Gujarat 
Type of Sponsor  Government medical college 
 
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 Snehal Baria  Government Akhandanand Ayurveda Hospital  OPD NO 4, Kayachikista Department, Government Akhandanand Ayurveda College Bhadra ,Ahmedabad,Gujarat
Ahmadabad
GUJARAT 
9825938166

snehalbaria97@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:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: DISEASES OF ENDOCRINE SYSTEM, (2) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: DHATUVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shad-dharana, Reference: Susruta Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Pippali , Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having clinical features of Hypothyroidism or patient who is already taking levothyroxine medicine.
Chronicity of Hypothyroidism below 10 years.
S.TSH>5 mIU/L
 
 
ExclusionCriteria 
Details  Patient with the age below 18 years and above 60 years.
Patients having any other major systemic diseases like Cancer, Tuberculosis, Type I Diabetes mellitus, Malignant hypertension, Thyrotoxicosis, Asthma, Heart disease, Pregnancy or any other debilitating disease which may lead to fatal condition for the patient at any time.
Patient having history of peptic ulcers, bleeding ulcers etc.
Patient with congenital or secondary Hypothyroidism or goiter.
Patients taking medicine for Hypothyroidism for more than 10 years.
If S.TSH level is more than 100mIU/L
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in sign and symptoms   56 days 
 
Secondary Outcome  
Outcome  TimePoints 
Results will be assessed on the basis of TSH score  56 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/07/2023 
Date of Study Completion (India) 10/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Hypothyroidism is one of the most common and challenging disease in today’s era. Hypothyroidism is a condition in which the thyroid gland does not produce enough Thyroxine(T4) and Tri-iodothyronine (T3). The prevalence of Hypothyroidism in India is about 11% of population. It is more prevalent in women than in male. Women are affected approximately six times more frequently than men.

Hypothyroidism may result from inadequate function of the gland itself (primary Hypothyroidism), inadequate stimulation by thyroid-stimulating hormone from the pituitary gland (secondary Hypothyroidism), or inadequate release of Thyrotropin releasing hormone from the brain’s hypothalamus (tertiary Hypothyroidism). Hashimoto’s Thyroiditis is the most common type, which have an autoimmune pathology. The other causes include thyroid radioactive iodine therapy, surgical removal of thyroid gland, drug induced, TSH deficiency etc.

                   Hypothyroidism is the second most common endocrine disorder observed all over world in present era. The standard treatment in Allopathy for Hypothyroidism is thyroid hormone supplement therapy with levothyroxine.

                       Management of Hypothyroidism with the modern drugs may bring the value of TSH and Thyroxine(T4) to normal range. The prolonged and increased dose of synthetic thyroxine may cause serious long term side effects or any other acute or chronic complications. So, to decrease the dosage of levothyroxine and to get rid of lifetime medication, we have a scope for Ayurvedic medicine. Thyroid hormone act as catalyst for metabolism in whole body. In Hypothyroidism, deficiency of thyroid hormone occurs which causes imbalance in metabolism leading to Dhatwagnimandya in terms of Ayurveda. The symptoms are Kapha-Vatapradhana. So, as per principles of Ayurveda, treatment should be Kapha Shamana, Vata Shamana and Agni dipana.

 

 

 
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