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CTRI Number  CTRI/2021/12/038762 [Registered on: 20/12/2021] Trial Registered Prospectively
Last Modified On: 06/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   DEVELOPMENT AND VALIDATION OF A TOOL FOR THE ASSESSMENT OF KOSHTHA 
Scientific Title of Study   A DESCRIPTIVE STUDY TO DEVELOP AND VALIDATE A TOOL FOR THE ASSESSMENT OF KOSHTHA AND ITS APPLICATION IN THE CONTEXT OF SNEHAPANA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meera K Bhojani 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kriya Sharir, All India Institute of Ayurveda, Sarita Vihar, New Delhi
Department of Kriya Sharir, All India Institute of Ayurveda, Sarita Vihar, New Delhi PIN - 110076
South
DELHI
110076
India 
Phone  9428570231  
Fax    
Email  ayumeerabhojani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Meera K Bhojani 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kriya Sharir, All India Institute of Ayurveda, Sarita Vihar, New Delhi
Department of Kriya Sharir, All India Institute of Ayurveda, Sarita Vihar, New Delhi PIN - 110076
South
DELHI
110076
India 
Phone  9428570231  
Fax    
Email  ayumeerabhojani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Meera K Bhojani 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kriya Sharir, All India Institute of Ayurveda, Sarita Vihar, New Delhi
Department of Kriya Sharir, All India Institute of Ayurveda, Sarita Vihar, New Delhi PIN - 110076
South
DELHI
110076
India 
Phone  9428570231  
Fax    
Email  ayumeerabhojani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautam Puri, Sarita Vihar, Madhura Road, New Delhi. PIN - 110076  
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 Arun Lal K  All India Institute of Ayurveda  Room No.312, Dept. of Kriya Sharir All India Institute of Ayurveda Sarita Vihar, New Delhi - 110076
South
DELHI 
9496334399

drarunlalk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are indicated for Sodhana Snehapana. 
 
ExclusionCriteria 
Details  Patients who are not indicated for Sodhana Snehapana. Patients with comorbidities, critically ill patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development and validation of Koshtha assessment tool.  22 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of Samyak Snigdha Lakshana with the previously obtained Koshtha assessment value.  28 Months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/09/2023 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION

            Ayurveda follows a holistic and patient-centric approach involving several subjective and objective parameters pertaining to disease as well as patients.

The term Koshtha can be described in two ways. Koshtha as an anatomical entity include all the organs of abdominal and thoracic cavity; Koshtha, as a physiological entity is the nature of digestive tract or hollow parts of body which represents motility of the intestines and movement of food and fecal matter in the alimentary canal and elimination of stool.

Understanding the limitations of mathematical calculations concerning to bio- physiology while dealing with a living body, Acharyas were of the opinion that the dose of any medicine should be fixed only after considering many factors including Koshtha & Prakriti; considering the individuality.

Koshtha plays an important role in selection the line of treatment of disease. Koshtha Parikshana is required before any Shodhana treatment. For selection of drug, Matra, Anupana, Snehapana etc. Koshtha assessment is necessary. Koshtha Pareeksha will help in the identification and better understanding of the Roga Marga and Samprapti of a disease.

According to Acharya Charaka, determination of Koshtha of an individual is done by Anumana and Yukti Pramana; by “Atura Pariprashna”. According to Acharya Vagbhata, diseases like Arsas, Atisara, Grahani etc. are interdependent on causative factors, including the status of Koshtha & Agni.

’Gut health’ is a term increasingly used in the medical literature and by the food industry. It covers multiple positive aspects of the gastrointestinal (GI) tract, such as the effective digestion and absorption of food, the absence of GI illness, normal and stable intestinal microbiota, effective immune status and a state of well-being.

 

BACKGROUND & RATIONALE

                        Currently, most Ayurveda research designs follow generic tools from classical textbooks which are not scientifically validated. There is always a need of developing and validating assessment tools for the unique health related concepts in Ayurveda.

Gut health can offer a new approach to preventive medicine if we learn more about how to achieve and maintain it. Current medical research is much more focused on the treatment of defined GI diseases rather than on the secondary or even primary prevention of disease.

The expression ’gut health’ lacks clear definition in the scientific literature, although it has been used repeatedly in human medicine and in animal health. Therefore, scientifically justified approaches to maintaining gut health and to preventing GI diseases are the need of the hour.1

A Koshtha assessment tool in the form of a questionnaire will be cost-effective, fast and non-invasive method, which might help in the better understanding of the condition and prevention / progress of the same; at the same time therapeutically for prescribing the adequate dosage of Sneha, Shodhana Dravyas, Pathya – Apathya and so on.


REVIEW OF LITERATURE

            The term Koshtha is derived from the word ‘Kush’ Shabda, which means Prajwalana, Daha or Paripaka. Or, it is the place where Paripaka takes place. The location of Koshtha is told as Kukshimadhyam.

            Koshtha, as an anatomical entity includes all the organs of abdominal and thoracic cavity. Acharyas Susruta, Vagbhata and Charaka names 8, 11 and 15 Koshthangas respectively.2 In other words, it is the potential space for the location of organs. ‘Mahasrotas’ or alimentary canal is also spoken of as Koshtha.

            Acharya Charaka, while explaining the Abhyantara Rogamarga, mentions the location of Koshtha as Shareeramadhya. He also mentions Mahanimna, Ama-Pakwasaya as the synonyms of Koshtha.

            Koshtha, as a physiological entity is the nature of digestive tract or hollow parts of body which represents motility of the intestines and movement of food and faecal matter in the alimentary canal, elimination and consistency of stool. According to Ayurveda, the predominance of Dosha in the Grahani represents the type of Koshtha.

            Koshtha is of three types. Namely, Mridu, Krura and Madhyama. Acharya Susruta explains Mridu Koshtha is of Pitta Dosha predominance; Krura Koshtha is of Vata-Kapha predominance and Madhyama Koshtha is of Sama Dosha, which is also called Sadharana Koshtha.3 Some acharyas are of the opinion that Krura Koshtha is constituted by Vata Dosha.

            In Vimana Sthana, Acharya Charaka explains Mridu-Darunatwam of Grahani should be assessed by Atura Pariprashna. In Sutra Sthana, on the context of Snehana, he explains a person of Mridu Koshtha is properly oleated by taking Sneha for three consecutive nights and one with Krura Koshtha needs the same for seven consecutive nights.4

Acharya Charaka goes on to explain: Guda, Ikshurasa, Mastu, Ksheera, Ulloditam, Dadhi, Payasa, Krisara, Sarpi, Kasmarya & Triphala Rasa, Draksha, Pilu Rasa, Ushna Jala or Truna Madya – intake of any of these will cause Virechana in Mridu Koshtha. But these cannot produce such purgative effect for those with Krura Koshtha, because their Grahani is too much dominated by Vata. Virechana is easy for those with Mridu Koshtha, because their Grahani is dominated by pitta and is least affected by Kapha and Vata.5

            Snehana stands for lubrication of body systems by the administration of fatty substances internally and externally. Snehapana (internal administration of sneha) is an important preparatory procedure for Panchakarma. Achhapana is the oral intake of medicated or non-medicated Sneha (Ghee/ oil) without mixing with food or other medicinal preparations and used for the purpose of softening and lubricating of body tissues prior to the Shodhana therapy.

Agnibala may be assessed in the patient prior to Snehapana, so as to assess the dose of Sneha dravya (Hina, Madhyama, Uttama, Hrisyasi matra). For the patient with unknown doshas, agni etc. one may start with Hrisyasi matra (which digests within two yamas).  

The patient who is intended to undergo Snehapana is to take the Sneha in the early morning (within 15 minutes of sunrise) in the prescribed dose based on his Agnibala (digestive capacity), nature of disease, condition of body etc. The usual dosage is between 50 to 75ml for Ghrita and 30 to 50 ml for Taila on the first day. The dose for the next day should be fixed after assessing the time taken for digestion. Hot water boiled with a piece of Shunthi (dry ginger) + Dhanyaka (dry coriander seeds) is given in small doses to enhance the digestion (Deepan, Pachana). Snehapana may be continued till Samyak Snigdha Lakshanas (symptoms of desired effect) are observed and usually it is obtained within 3 to 7 days.

 

OBJECTIVES

PRIMARY

·       To develop and validate a questionnaire using Ayurveda parameters, for the clinical evaluation of Koshtha in an individual.

 

SECONDARY

·      To explore the relationship between Koshtha and Prakriti of an individual.

·      To explore the relationship between Koshtha and Agni of an individual.

 

METHODOLOGY

Tool Development Process – Conceptual & Fundamental Study

Nature of measure      -           Qualitative

Type of instrument     -           Structured, disguised closed ended questionnaire

 

MATERIALS AND METHODS

 

Phase - I / Preliminary Phase

Defining Koshtha and factors to be considered for its assessment

Ø  Literature review

Ø  Consensus method with experts, academicians – via Delphi survey and nominal group technique.

Phase – II: Tool Development and Validation

1.     Item generation and response scales:

·       Using same methods as in preliminary phase.

·       Generating the domains pertaining to assess the Koshtha;

·       Framing questions and sub questions for the assessment of each domain.

2.     Selection of Type of response, response scales and formats

·       Response for each item will be decided through the same methods.

·       Dichotomous response

·       Continuous – Likert’s scale

3.     Pre-testing questionnaire:

·       Face validity               -           Expert evaluation

·       Content validity          -           Small sample study (10-30 respondents)

·       Cognitive interview    -           Small sample study (5-10 experts) - Tested for comprehension, retrieval, judgement & response.

·       Translation & back translation - Language experts - Tested for relevance, clarity, simplicity and ambiguity.

·       Reliability assessment :

Internal consistency (Homogeneity)  -            Cronbach’s α

Test- Retest Reliability (Stability)

·       Item Revision

4.     Empirical Evaluation:

Application of the validated tool in field trials (large sample study) in healthy (swastha) volunteers.

Sample size: Sample size will be calculated according to the number of questions generated. After discussing with the experts, it was decided that 8 (eight) participants will be included in the study for each question generated. (A minimum of 100 respondents). Based on the thumb rule, the sample size has been calculated.

After searching in the public domain for a standard, validated tool for the assessment of Koshtha, it was found that none such tool is published till date; hence in this study, development of such a gold standard tool is being attempted.

Koshtha & Prakriti of the healthy volunteers will be assessed based on the prepared questionnaire. Among various methods mentioned by Acharya, Go Ksheera (Cow’s milk) maybe selected, considering its wide acceptancy and availability. Double the quantity of daily consumption of Go Ksheera (Cow’s milk) may be given at time past Sleshma Kaala; and status of Koshtha may be assessed based on its action in Mala Pravritti.

Tool is tested for:

·       Construct validity

·       Criterion validity  -           Panel diagnosis

·       Factorial validity  -           Degree up to which individual items are measuring a common domain.

 

Phase – III: Diagnostic Test Assessment

The tool is applied in analytical studies to test Specificity, Sensitivity, Predictive values and Likelihood ratios. Sensitivity will be assessed by finding out the proportion of the people with a particular Koshtha status, who get the same result after using the developed questionnaire. Specificity will be assessed by finding out the people without a particular Koshtha status, among those who tested negative for a particular Koshtha, after using the developed questionnaire.

In the present study, a tool for the assessment of Koshtha will be developed and validated after collecting all the information available in the Ayurvedic classical literature and discussing with the subject experts. Here, Snehapana is only used as a tool to assess the status of Koshtha of an individual, via Samyak Snigdha Lakshana.

STUDY DESIGN                  -           Descriptive study

STUDY AREA                      -           Delhi

STUDY SETTING                -           All India Institute of Ayurveda

PERIOD OF STUDY            -           3 years

STUDY POPULATION:

â—¦       Inclusion criteria: Age 30 to 60 years; irrespective of sex, religion, occupation and socio-economic status; devoid of any comorbidities; Patients who are indicated for Sodhana Snehapana

â—¦       Exclusion criteria: Age below 30 years and above 60 years. Patients with comorbidities, critically ill patients.

METHODOLOGY:

â—¦       Patients undergoing Sodhananga Snehana in IPD of AIIA will be selected after getting their consent.

â—¦       Koshtha of the patients will be assessed based on the prepared questionnaire.

â—¦       Fixed amount of Sneha will be given to the patients, as Accha Sneha as part of Shodhananga Snehana.

â—¦       Type and quantity of Sneha used, and the time taken for the digestion on each day will be strictly monitored and noted.

â—¦       Assessment of appearance of Samyak Snigdha Lakshana will be correlated with the previously obtained Koshtha assessment value.

â—¦       All the data obtained will be statistically analyzed.

Proposed furtherance:

â—¦       Gut microbiota studies of selected individuals belonging to each Koshtha will be done after discussing the feasibility.

â—¦       If time permits, development of a mobile app on the Koshtha assessment tool, after discussing the feasibility.


Cooperation required:

1.     Department of Panchakarma

Help from other Departments of AIIA, Sarita Vihar will be taken with due permission from concerned authority whenever needed.

 

Financial Support:

The financial support for present study will be as per the institutional policy.

1.     Remuneration of experts: Depends on the number of experts and number of sessions required. By international standards, Rs.2000/- per hour for each.

So, five sessions with 10 experts: Rs.100000/- approximately.

 

REFERENCES


1.     Bischoff, S.C. ’Gut health’: a new objective in medicine?. BMC Med 9, 24 (2011). https://doi.org/10.1186/1741-7015-9-24

2.     Acharya Jadavji Trikamji (2002) Sushruta Samhita, 7 edn., Varanasi: Chaukhambha Orientalia. Chikitsa Sthana, 2/12, Agnivesha (2001) Charaka Samhita, 5 edn., Varanasi: Chaukhambha Orientalia. Sarira Sthana 7/10, Vagbhatacharya (2006) Ashtanga Hridaya, Reprint 2006 edn., Varanasi: Chaukhambha Orientalia. Sarira Sthana, 3/12.

3.     Acharya Jadavji Trikamji (2002) Sushruta Samhita, 7 edn., Varanasi: Chaukhambha Orientalia. Chikitsa Sthana, 33/21

4.     Agnivesha (2001) Charaka Samhita, 5 edn., Varanasi: Chaukhambha Orientalia. Vimana Sthana 4/8.

5.     Agnivesha (2001) Charaka Samhita, 5 edn., Varanasi: Chaukhambha Orientalia. Sutra Sthana 13/66

6.     Edavalath M, Bharathan BP. Methodology for developing and evaluating diagnostic tools in Ayurveda - a review. J Ayurveda Integr Med. 2021 Mar 4:S0975-9476(21)00010-3. doi: 10.1016/j.jaim.2021.01.009. Epub ahead of print. PMID: 33678559.

7.     Dr. Shriram Shivajirao Ragad, & Dr. Maya Vivek Gokhale. (2019). AYURVEDIC CONCEPT OF KOSHTHA AND ITS IMPORTANCE IN PANCHKARMA. International Journal of Research - Granthaalayah, 7(7), 416–421. http://doi.org/10.5281/zenodo.3370488

 
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