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CTRI Number  CTRI/2022/04/041758 [Registered on: 08/04/2022] Trial Registered Prospectively
Last Modified On: 04/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative study on Pathya Aahara and Yoga in autoimmune hypothyroidism A Comparative Study on Pathya Aahara and Yoga in Autoimmune Hypothyroidism  
Scientific Title of Study   A Comparative study on efficacy of Pathya Aahara and Yoga in Subclinical Hashimotos Thyroiditis With Respect to Agnimandya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Rai 
Designation  MD Scholar 
Affiliation  shri Narayan Prasad Awasthi Government Ayurved College Raipur 
Address  OPD No 6 Department of Swasthavritta And Yoga Shri khudadad dungaji Govt Ayurveda Hospital G E Road Raipur(CG) 492010 CHHATTISGARH
Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C G) G E Road Raipur 492010 CHHATTISGARH
Raipur
CHHATTISGARH
492010
India 
Phone  9530605602  
Fax    
Email  shwetamalethia5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Sharma 
Designation  Professor 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur 
Address  OPD No 6 Department of Swasthavritta And Yoga Shri khudadad dungaji Govt Ayurveda hosiptal G E Road Raipur(CG) 492010 CHHATTISGARH
Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Government Ayurved College Raipur (C G) G E Road Raipur 492010 CHHATTISGARH
Raipur
CHHATTISGARH
492010
India 
Phone  9827115211  
Fax    
Email  ansharma260@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shweta Rai 
Designation  MD Scholar 
Affiliation  Shri Narayan Prasad Awasthi Govt Ayurved College Raipur 
Address  OPD No 6 Department of Swasthavritta And Yoga Shri khudadad Dungaji Govt Ayurveda Hospital G E Road Raipur (CG) 492010 CHHATTISGARH
Department of Swasthavritta And Yoga Shri Narayan Prasad Awasthi Government Ayurved College Raipur(C G) G E Road Raipur 492010 CHHATTISGARH
Raipur
CHHATTISGARH
492010
India 
Phone  9530605602  
Fax    
Email  shwetamalethia5@gmail.com  
 
Source of Monetary or Material Support  
Department of Swasthavritta and Yoga Shri Narayan Prasad Awasthyi Govt Ayurved College Raipur (CG)  
 
Primary Sponsor  
Name  Shri Narayan Prasad Awasthi Govt Ayurveda College Raipur Chattisgarh 
Address  Shri Narayan Prasad Awasthyi Govt Ayurved College Raipur (CG) GE Road Raipur 
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 
Shweta Rai  Shri Khudadad Dungaji Government Ayurved Hospital  OPD NO 6 Department of Swasthvritta and Yoga Shri Khudadad Dungaji Government Ayurveda Hospital Raipur C G 492010
Raipur
CHHATTISGARH 
9530605602

shwetamalethia5@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:E063||Autoimmune thyroiditis. Ayurveda Condition: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Adviced to 1.Wake up before sunrise 2.Practice Yoga and Pranayam (empty stomach) 3.Have meals at fixed time and eat Pathya food 4.Have dinner before 8pm and go to bed before10 pm., Ritucarya: Advice to 1. Avoid day time sleep. 2. To practice, Aahara vihara according to Ritu., Acara Rasayana:Adviced to practice 1. Truthfullness 2.To be free from anger. 3.Regular practice charity 4.Have good self control 5. Free from ego, Other:, Pathya/Apathya:yes, Pathya:All green vegetables, Fruits(pomgranate,Apple, Tender coconut,pear, pappaya,, bannana Mong dal,Rice, Moth Use earthen vesseles, iron and steel vessels for cooking, Apathya:Dugdha ikshu vikaara(sweet, cheese, milk products, added sugar) junk food, deep fried food items,refiend flour products,preservatives avoid-Aluminium, nonstick vessels for cooking, avoid plastic
2Intervention ArmProcedure-nadi shodhana pranayam , bhujangasana, marakatasana (Procedure Reference: hatha yoga pradipika, Procedure details: yogasana will be adviced to practice in morning time empty stomach duration as per capacity of patient)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient age between 18 to 60 years.
2. Selection of patients irrespective of race,
religion, sex socio economic, statuary
marital status etc.
3. Patient not taking levothyroxin or any other
medication for thyroid.
4. TSH from 5 uIU/ml to 10 uIU/ml.
5. T3 and T4 should be within normal range.
6. Either of the two Antibody test should be Positive
Anti TPO antibody (Thyroid peroxidase)
Anti TG antibody ( Thyroglobulin)
7. Patient who have given written consent. 
 
ExclusionCriteria 
Details  1. TSH level > 10uIU/ml.
2. T3 and T4 level is lower than normal range.
3. If both antigen test are negative (Anti TPO & Anti TG antibody)
4. Patient suffering from another chronic systemic disease or autoimmune disease.
5. Patient underwent any thyroid surgery or already diagnosed case of carcinoma.
6. Patient with long term steroid treatment.
7. Patient who has not given written consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
symptoms such as Fatigue, Loss of appetite, weight gain, Constipation, Menstrual irregulerities, Brain fog etc will be reduced in Subclinical Hashimoto Thyroiditis.  4 week 
 
Secondary Outcome  
Outcome  TimePoints 
TSH ,t3 ,t4 will be assessed and symptoms such as Fatigue ,Loss of appetite, Weight gain, Constipation, Menstrual irregularity, Sleep, Brain fog will also be assessed   90 days 
 
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 
Date of First Enrollment (India)   01/05/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION:

In the ancient science of Ayurveda, Agni is the one of the most important concept. Acharyas explained Mandagani as the cause of all disease conditions [1]. Balanced Agni in body leads to long and healthy life and imbalanced Agni results to (Rogavastha) state of disease in human.[2].There are various causes at various level of Agni (Jatharagni, Bhutagni and Dhtvagni) leading to Mandagani. This reduced digestive fire (Mandagani) leads to Ama formation i.e. incompletely digested food, Ama leads to state of Sthrotodusthi and ultimately formation of disease in body [3].

Ama is a pathological qualitative change in a substance during the process of paka may be at Jatharagni, Bhutagni or Dhtvagni level. So during the digestion process if a food substance attain certain pathological qualities without attaining finality, such substance is called as Ama [4].Pratyatmakaguna of Ama are – Drava, Guru, Snigdha, Piscilata, Tantum, Avipakam, Asamyuktam, Durgandhyam Abhisyandi, Srotoavarodha, Katu – Amala rasa, Sukatata[5]

The factors causing Mandagnii.e.Disturbance of Agni can be classified into two types:

1.     Direct Factors: causing direct influence on Agni. E.g.Ansana, Adhyasana, Ajirna ahara, Virudhahara, Apkwa, Vidgdha Ahara etc.

2.     Indirect factors: Have no direct influence on Agnie.g. any disorder leading to Agni Mandya at various stages, Stress, All causes which firstly triggers the Dosha and than Agni.

Hashimoto’s Thyroid disease is an autoimmune condition in which body’s immune cells mistakenly attacks the healthy cells of thyroid gland and gradually failure of thyroid gland. At early stages anti thyroid antibodies are present in body but symptoms may not appear, over the time patient starts experiencing symptoms such as fatigue, weight gain, constipation, hair loss etc along with increased level of Thyroid Stimulating Hormone (TSH). If the level of TSH are 10uIU/ml or less than 10uIU/ml(but above normal range i.e. 5uIU/ml) and peripheral T3 and T4 level within normal range, it is called subclinical hypothyroid mean patients thyroid gland is underperforming and producing less hormone, but body is managing to keep T3 and T4 levels normal by increasing TSH by pituitary gland.

If patient remain untreated and undiagnosed at this stage, the condition results in overt hypothyroidism i.e. clinical hypothyroidism with elevated TSH levels and low T4. At this stage thyroid gland is unable to secret enough T3 and T4 even by increasing TSH levels by pituitary gland, ultimately leads to very high TSH levels and decreased T3 and T4 levels in body. In Ayurveda there is no direct description of hypothyroid or autoimmune disease (Hashimoto’s Thyroiditis). But its symptoms have very close resemblance with symptoms of Amaand Strotodusti such as Gaurav, Shathilya, Avipaka, Avasada, Tandrai.Rasavaha Stroto Dusti Lakshana – loss of appetite, sluggishness, dry hair and skin, anemia and constipation. MedovahaStroto Dusti Lakshana – Abnormal weight gain, tiredness etc. Acharya Charka explained that one should not ashamed if name can’t be given to a pathological condition; instead he should focus on Dosha and Lakshana and treat accordingly.[6][7]

On the basis ofDosha, Samuthan, Sansthana etc disease can be countless.

In Charak Samhita[8]Virudha dusta asuchi bhojana is told to be one of the cause of Manovahastrotodusti and Unmda indicating relation of food and mental issue. Also in Charaka Vimana Sthana ch.5/13 explains ‘Chintyanam Atichintanaat’[9] as cause of Rasavaha Strotodusti.The one who follow the Pathya Aahar Vihar remains disease free so there is no need of taking medicine and diseased one who doesn’t follow Pathya also does not need medicine as it will not be fruitful.

Nadishodhana Pranayama causes Agnideepana and Krishta karaka effect on body, it calms the mind and improve gut functioning.[10]Markatasana and Bhujangasana also elevate the Agni and improve digestion system thus all these Asana could improve outcome of thyroid management. [11]

Some studies in modern science also emphasis upon role of gut in autoimmunity, gut – immunity – brain axis.

Modified food patterns and compositions (e.g. sugary, fried fatty foods) results in

Inflammation of gut lining

+

Change in gut micro biome

                                                                          Causes

 

Cause malabsorption of nutrients which are essential for thyroid regulation.

e.g. vitamin D – Regulates immune system

Zinc & Selenium – Necessary for T4 to T3 conversion.

Iodine– For Thyroid Hormone synthesis

Increased permeability of gut lining

 


Easily allows the antigen to enter circulation

 


Trigger immunity

Modulate the activation of different sensory receptor in the gut and consequently stimulate and regulate process of hormone release.

[12]

 

Both luminal nutrients and micro biome metabolite stimulate enteroendocrine cells located throughout GI tract, which represent large endocrine organ in body. [13]

Gut micro biota determine what the host is capable of extracting from diet and nutrients to bioactive signaling molecule that influence brain function and host behavior. [14]

NEED OF STUDY:

Autoimmunity is the case of hypothyroidism in 90% adult hypothyroidism. [15] 3-8% percent population has subclinical hypothyroidism out of which 80% are autoimmune positive [16].

Presently there is no cure for autoimmune thyroid disease. In Ayurveda various researches has done on role of Yoga in stress management, hormonal balance and digestion improvement .As stress and Agnimandya has a huge role in onset of Autoimmune thyroid condition, early Ayurvedic intervention by Yoga and Pathya Aahara could be helpful in Hashimoto’s thyroiditis patients.

1.     Progression of disease can be stopped at early stage.

2.     Complications such as complete thyroid failure, CA thyroid etc can be prevented.

3.     Future development of another autoimmune disease can be prevented such as celiac disease, vitiligo, multiple sclerosis and SLE etc.

Keeping all above aspects in mind I have selected the topic. 
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