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CTRI Number  CTRI/2025/11/096905 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 13/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding Hypothyroidism from an Ayurvedic View through shatkriyakal 
Scientific Title of Study   Conceptual Study Of Hypothyroidism An Ayurvedic Perspective with Special Reference to Shatkriyakal 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nilesh Londhe 
Designation  PhD scholar 
Affiliation  Dr.D.Y.Patil College of Ayurved and Research Centre, Pimpri 411018 
Address  Fourth Floor Department of Ayurved Samhita Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018
Fourth Floor Department of Ayurved Samhita Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018
Pune
MAHARASHTRA
411018
India 
Phone  9881572395  
Fax    
Email  drnileshlondhe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhrigupati Pandey 
Designation  Professor 
Affiliation  Dr.D.Y.Patil College of Ayurved and Research Centre, Pimpri 411018 
Address  Fourth Floor Department of Ayurved Samhita Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018
Fourth Floor Department of Ayurved Samhita Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018
Pune
MAHARASHTRA
411018
India 
Phone  9922430457  
Fax    
Email  bhrigupati.pandey52@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhrigupati Pandey 
Designation  Professor 
Affiliation  Dr.D.Y.Patil College of Ayurved and Research Centre, Pimpri 411018 
Address  Fourth Floor Department of Ayurved Samhita Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018
Fourth Floor Department of Ayurved Samhita Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018

MAHARASHTRA
411018
India 
Phone  9922430457  
Fax    
Email  bhrigupati.pandey52@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurved and Research Centre Pimpri, Pune-411018 Nirvikar Ayurved Hospital, B wing ,First floor , Jay Ganesh Samrajya, Pune-Nashik Highway, Bhosari- 39  
 
Primary Sponsor  
Name  Dr Nilesh Londhe 
Address  Dr D Y Patil College of Ayurved and Research Centre Pimpri, Pune Pin code-411018 Maharashtra, India 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nilesh Londhe  Dr D Y Patil College of Ayurved and Research Centre, Pimpri 18  OPD NO.5 Kayachikitsa GROUND Floor Dr.D.Y.Patil College of Ayurved and Research Centre Pimpri 411018
Pune
MAHARASHTRA 
9881572395

drnileshlondhe@gmail.com 
Dr Nilesh Londhe  Nirvikar Ayurved Hospital  OPD No.2 First Floor Bwing Jay Ganesh Samrajya Bhosari Pune-411039
Pune
MAHARASHTRA 
9881572395

drnileshlondhe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
DR DYPCA and RC INSTITUTIONAL ETHICS COMMITTEE  Approved 
Institutional Ethics Committee Nirvikar Ayurved Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient diagnosed with Hypothyroidism, undergoing treatment of any pathy for up to one year 
 
ExclusionCriteria 
Details  Patient undergoing treatment for more than one year, patinet suffering from congenital Hypothyroidism , Hypothyroidism after surgery or accident, partial or total removal of gland 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the conceptual study of Shatkriyakal in relation with Pathogenesis of Hypothyroidism  Screening will be done on 150 patients 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the correlation between Dosha, Dhatu, Srotas, Mala and Aam in patients with Hypothyroidism  Screening will be done on 150 patients with the help of questionnaire 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   01/12/2028 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Ayurveda, our cultural heritage, is the ancient system of medicine, serving living beings since time immemorial. It is a unique system, in the sense of its fundamental doctrines and concepts. Kriyakal is one of the various important concepts described in Ayurveda treatises. Kriyakal means opportunity or time to administer treatment. These are six in number and are hence known as Shatkriyakal viz. sanchaya, prakopa, prasara, sthansamshraya, vyakti and bheda. Acharya Sushruta has discussed about Shatkriyakal in his treatise in the chapter entitled ‘Vran-prashna Adhyay’. It is a phenomenon observed in almost all the disorders. The concept of Shatkriyakal is applicable in nidana aspect for proper diagnosis and gives an idea to plan the line of treatment of that disease. The duration of a particular stage depends upon the virility of nidana and swiftness of dosha which in turn depends upon the triggering factors and nature of the disorder. Early diagnosis of a disease helps to cure the disease without much discomfort. Shatkriyakal the Kriyakal are six in number viz. Sanchaya (stage of accumulation), Prakopa (stage of inclination or aggravation), Prasara (stage of migration or spreading), Sthana- samshraya (stage of localization), Vyakti (stage of manifestation) and Bheda (specification of dosha and their complications). Physician is able to detect the changes in early stages like sanchaya, prakopa etc. based on the manifestations of dosha and advise the correct treatment at that stage, disease progress can be checked and homoeostasis can be restored.

Brief review of the same is as follows1.

1.     Sanchaya: First stage of Kriyakal is known as Sanchaya meaning collection, putting together i.e. the accumulation of dosha due to various nidana factors. In this stage, dosha get accumulated but they do not leave their own place and this state of dosha is known as sanchaya.

2.     Prakopa: When the dosha are in sanchaya condition, if nidana intake persists, dosha prakopa stage follows. Prakopa stage is limited to the state of readiness of dosha to move from its own place. This means that dosha increases in quantity and is.

3.     Prasara: It is the third stage of Kriyakal. If nidana- sevan (indulgence in causes of disease) is continued and prakopavastha is not encountered, the dosha will move to the stage of prasara. In prakopa state, dosha get excited and are ready to move, whereas in prasara they overflow or spread or will move to other organs.

4.     Sthana Samshraya: If continuation of etiological factor persists in prasara- avastha, dosha or dosha move further, into the stage of sthana- samshraya. Vitiated dosha in circulation settle wherever srotavaigunya is present. This settlement of dosha at a place is called sthana- samshraya.

5.     Vyakti: It is the fifth stage of Kriyakal. If nidana is continuously present in the stage of sthansamshraya, dosha enters Vyaktibhava stage. Vyadhidarshana, meaning appearance of all signs and symptoms of the disease, is a result of this stage.

6.     Bheda: It is the sixth stage of Kriyakal means specification of dosha and their complications .wherein they burst and become ulcers and in case of fever, diarrhea etc. attain chronicity. If the disease is untreated or improperly treated in Vyaki- avastha, then it lands in this succeeding stage of Bhedavastha wherein it gives birth to another disease or diseases which are called Upadrava (complications). If not treated properly, it becomes incurable.

Importance of Kriyakal Dosha, if eliminated in the stage of accumulation do not attain successive stages. They become stronger as they proceed further. Treatment in earlier stages is easier than in later stages. Kriyakal are useful to know the prognosis of the disease and in the decision of treatment strategy. If dosha are treatable then their elimination is prescribed in three ways according to the condition of the dosha- if there is abundance of dosha, evacuation is recommended, in case of moderate presence, lightening and digestion, while in limited dosha, pacification is useful. While stating the significance of Shatkriyakal,

Acharya Sushruta has stated, that one who knows the accumulation, aggravation, spread, localization, manifestation and specification of dosha and their complications is the real physician.

 

This concept of Shatkriyakal is well explained for the diseases explained in ayurvedic text. But Nowadays, we Ayurvedic Physicians come across many newer diseases (Anukt Vyadhi) like Autoimmune diseases, Hormonal disorders wiz. Hypothyroidism, Addison’s disease, Cushing’s syndrome, Graves’ disease (type of hyperthyroidism resulting in excessive thyroid hormone production), Hashimoto’s thyroiditis (autoimmune disease). Researchers, the Ayurvedic Vaidya’s ’s are many a times get enquiries like do Ayurveda treats diseases like Hypothyroidism, Addison’s disease, Cushing’s syndrome, Graves’ disease, etc.? To answer this question the Ayurvedic Vaidya’s must know how to elaborate these diseases in terms of Ayurveda. To elaborate this one must know the concept of Shatkriyakal. To explain this concept of Shatkriyakal we decided to elaborate the disease process of Hypothyroidism.

 

Hypothyroidism is characterized by a broad clinical spectrum ranging from an overt state of myxedema, end organ effects and multisystem failure to an asymptomatic or subclinical condition with normal levels of thyroxine (T4) and tri-iodothyronine (T3) and mildly elevated levels of serum thyrotropin. Hypothyroidism is defined as reduced production of thyroid hormones. The causes of hypothyroidism are various and are usually divided into two categories: first, the permanent loss or destruction of the thyroid through processes such as autoimmune diseases is described as primary hypothyroidism, which is the cause of approximately 99% of cases of hypothyroidism; second, insufficient stimulation of the normal thyroid gland as a result of a hypothalamic or pituitary disease or defects in the TSH molecule is called central or secondary hypothyroidism. Hypothyroidism can affect all organ systems and its clinical presentations vary with the severity of thyroid hormone deficiency and the length of time the body has been deprived of the proper amount of the hormones. Signs and symptoms in adults may include fatigue and sluggishness, increased sensitivity to cold, constipation, pale and dry skin, brittle fingernails and hair, a puffy face, hoarse voice, an elevated blood cholesterol level, unexplained weight gain, muscle aches, tenderness, stiffness and weakness, pain, stiffness or swelling in the joints, heavier than normal menstrual periods, and depression. Hypothyroidism in infants and teenagers may result in poor growth and mental development as well as delayed development of permanent teeth and puberty.

The major function of the thyroid gland is to act as a spark for the maintenance of oxidative metabolism in most tissues. In Ayurveda parlance, this is attributed as the function of Agni (system related to metabolism). As far as the management of hypothyroidism through Ayurveda is concerned, hormonal replacement is not possible through drugs. However, one can interpret the pathogenesis of hypothyroidism in the context of Ayurveda, can treat the pathology accordingly. Here we have decided to explain the Nij Samprapties of disease only not the Agantu one. Here we will try to elaborate different Samprapties or pathological process of Hypothyroidism.

 
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