DEVELOPMENT AND VALIDATION OF A TOOL FOR THE ASSESSMENT OF KOSHTHA

Not yet recruiting

Conditions: Other general symptoms and signs,

Registration Number: CTRI/2021/12/038762

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: **INTRODUCTION**

*Ayurveda* follows a holistic and patient-centricapproach involving several subjective and objective parameters pertaining todisease as well as patients.

The term *Koshtha*can be described in two ways. *Koshtha* as an anatomical entity includeall the organs of abdominal and thoracic cavity; *Koshtha,* as aphysiological entity is the nature of digestive tract or hollow parts of bodywhich represents motility of the intestines and movement of food and fecalmatter in the alimentary canal and elimination of stool.

Understandingthe limitations of mathematical calculations concerning to bio- physiologywhile dealing with a living body, *Acharyas* were of the opinion that thedose of any medicine should be fixed only after considering many factorsincluding *Koshtha* & *Prakriti*; considering the individuality.

*Koshtha* plays an important rolein 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 ofthe *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 â€œ*Atura* *Pariprashna*â€.According to *Acharya* Vagbhata, diseases like *Arsas*, *Atisara*,*Grahani* etc. are interdependent on causative factors, including thestatus 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 asthe effective digestion and absorption of food, the absence of GI illness,normal and stable intestinal microbiota, effective immune status and a state ofwell-being.

**BACKGROUND & RATIONALE**

Currently, most *Ayurveda* researchdesigns follow generic tools from classical textbooks which are notscientifically validated. There is always a need of developing and validatingassessment tools for the unique health related concepts in *Ayurveda*.

Gut health canoffer a new approach to preventive medicine if we learn more about how toachieve and maintain it. Current medical research is much more focused on thetreatment of defined GI diseases rather than on the secondary or even primaryprevention of disease.

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

A *Koshtha*assessment tool in the form of a questionnaire will be cost-effective, fast andnon-invasive method, which might help in the better understanding of thecondition and prevention / progress of the same; at the same timetherapeutically for prescribing the adequate dosage of *Sneha,* *ShodhanaDravyas*, *Pathya* â€“ *Apathya* and so on.

**REVIEW OF LITERATURE**

The term *Koshtha* is derived from the word â€˜*Kushâ€™**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 theorgans of abdominal and thoracic cavity. *Acharyas* Susruta, Vagbhata andCharaka names 8, 11 and 15 *Koshthangas* respectively.2 Inother words, it is the potential space for the location of organs. â€˜*Mahasrotasâ€™*or alimentary canal is also spoken of as *Koshtha.*

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

*Koshtha,* as a physiological entity is the natureof digestive tract or hollow parts of body which represents motility of theintestines and movement of food and faecal matter in the alimentary canal, eliminationand 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 properlyoleated by taking *Sneha* for three consecutive nightsand one with *Krura Koshtha* needs the same for seven consecutive nights.4

*Acharya* Charaka goes on toexplain: *Guda, Ikshurasa, Mastu, Ksheera, Ulloditam, Dadhi, Payasa, Krisara,Sarpi, Kasmarya & Triphala Rasa, Draksha, Pilu Rasa, Ushna Jala or Truna Madya*â€“ 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* isdominated by *pitta* and is least affected by *Kapha* and *Vata*.5

*Snehana* stands for lubrication of body systems by the administrationof fatty substances internally and externally. *Snehapana* (internaladministration 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 thepurpose of softening and lubricating of body tissues prior to the *Shodhana*therapy.

*Agnibala* may be assessed in thepatient 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 patientwho is intended to undergo *Snehapana* is to take the *Sneha* in theearly morning (within 15 minutes of sunrise) in the prescribed dose based onhis *Agnibala* (digestive capacity), nature of disease, condition of bodyetc. The usual dosage is between 50 to 75ml for *Ghrita* and 30 to 50 mlfor *Taila* on the first day. The dose for the next day should be fixedafter 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 toenhance the digestion (*Deepan, Pachana*). *Snehapana* may becontinued till *Samyak Snigdha Lakshanas* (symptoms of desired effect) areobserved and usually it is obtained within 3 to 7 days.

**OBJECTIVES**

PRIMARY

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

SECONDARY

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

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

**METHODOLOGY**

**Tool Development Process â€“Conceptual & Fundamental Study**

Nature of measure      -           Qualitative

Type of instrument     -           Structured,disguised closed ended questionnaire

**MATERIALS AND METHODS**

**Phase - I / PreliminaryPhase**

Defining *Koshtha* andfactors to be considered for its assessment

Ã˜ Literature review

Ã˜ Consensus method withexperts, academicians â€“ via Delphi survey and nominal group technique.

**Phase â€“ II: ToolDevelopment and Validation**

1.     Item generation andresponse scales:

Â·      Using same methods as in preliminary phase.

Â·      Generating the domains pertaining to assess the *Koshtha;*

Â·      Framing questions and sub questions for the assessment ofeach domain.

2.     Selection of Type ofresponse, response scales and formats

Â·      Response for each item will be decided through the samemethods.

Â·      Dichotomous response

Â·      Continuous â€“ Likertâ€™s scale

3.     Pre-testing questionnaire:

Â·      Face validity               -           Expert evaluation

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

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

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

Â·      Reliability assessment :

Internalconsistency (Homogeneity) -            Cronbachâ€™s Î±

Test- RetestReliability (Stability)

Â·      Item Revision

4.     Empirical Evaluation:

Application of thevalidated tool in field trials (large sample study) in healthy (*swastha*)volunteers.

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

Aftersearching in the public domain for a standard, validated tool for theassessment of *Koshtha*, it was found that none such tool is publishedtill date; hence in this study, development of such a gold standard tool isbeing attempted.

*Koshtha* & *Prakriti* of thehealthy volunteers will be assessed based on the prepared questionnaire. Amongvarious methods mentioned by *Acharya*, *Go* *Ksheera* (Cowâ€™smilk) maybe selected, considering its wide acceptancy and availability. Doublethe quantity of daily consumption of *Go Ksheera* (Cowâ€™s milk) may begiven at time past *Sleshma* *Kaala*; and status of *Koshtha*may be assessed based on its action in *Mala Pravritti*.

Tool is tested for:

Â·      Construct validity

Â·      Criterion validity -           Panel diagnosis

Â·      Factorial validity -           Degree up to which individual itemsare measuring a common domain.

**Phase â€“ III: DiagnosticTest Assessment**

The tool is applied inanalytical studies to test Specificity, Sensitivity, Predictive values andLikelihood ratios. Sensitivity will be assessed by finding out the proportionof the people with a particular *Koshtha* status, who get the same resultafter using the developed questionnaire. Specificity will be assessed byfinding out the people without a particular *Koshtha* status, among thosewho tested negative for a particular *Koshtha*, after using the developedquestionnaire.

In the presentstudy, a tool for the assessment of *Koshtha* will be developed andvalidated after collecting all the information available in the Ayurvedicclassical 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** -           3years

**STUDY POPULATION:**

â—¦      Inclusion criteria: Age 30 to 60 years; irrespective of sex,religion, occupation and socio-economic status; devoid of any comorbidities; Patientswho 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 AIIAwill be selected after getting their consent.

â—¦       *Koshtha* of the patients will be assessed based on the preparedquestionnaire.

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 strictlymonitored and noted.

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

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

**Proposed furtherance:**

â—¦      Gut microbiota studies ofselected individuals belonging to each *Koshtha* will be done afterdiscussing the feasibility.

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

**Cooperation required:**

1.    Department of Panchakarma

Help fromother Departments of AIIA, Sarita Vihar will be taken with due permission fromconcerned authority whenever needed.

**Financial Support:**

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

1.    Remuneration of experts:Depends on the number of experts and number of sessions required. Byinternational 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?. *BMCMed* **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) *CharakaSamhita*, 5 edn., Varanasi: Chaukhambha Orientalia. Sarira Sthana 7/10, Vagbhatacharya(2006) *Ashtanga Hridaya*, Reprint 2006 edn., Varanasi: ChaukhambhaOrientalia. 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 evaluatingdiagnostic tools in Ayurveda - a review. J Ayurveda Integr Med. 2021 Mar4: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. InternationalJournal of Research - Granthaalayah, 7(7), 416â€“421. <http://doi.org/10.5281/zenodo.3370488>

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients who are indicated for Sodhana Snehapana.

Exclusion Criteria

Patients who are not indicated for Sodhana Snehapana.
Patients with comorbidities, critically ill patients.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development and validation of Koshtha assessment tool.	22 Months

Secondary Outcome Measures

Name	Time	Method
Correlation of Samyak Snigdha Lakshana with the previously obtained Koshtha assessment value.	28 Months

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
South, DELHI, India
All India Institute of Ayurveda
🇮🇳South, DELHI, India
Dr Arun Lal K
Principal investigator
9496334399
drarunlalk@gmail.com