A DESCRIPTIVE STUDY TO DEVELOP AND VALIDATE A TOOL FOR THE ASSESSMENT OF KOSHTHA AND ITS APPLICATION IN THE CONTEXT OF SNEHAPANA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Development and validation of Koshtha assessment tool.
研究概览
简要总结
INTRODUCTION
Ayurveda follows a holistic and patient-centricapproach involving several subjective and objective parameters pertaining todisease as well as patients.
The term Koshthacan 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 Parikshanais 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 AcharyaCharaka, determination of Koshtha of an individual is done by Anumanaand Yukti Pramana; by “Atura Pariprashnaâ€.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 Koshthaassessment 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 – 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 Koshthais 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. ‘*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 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 Doshain the Grahani represents the type of Koshtha.
Koshtha is of three types. Namely, Mridu, Kruraand Madhyama. Acharya Susruta explains Mridu Koshthais of Pitta Dosha predominance; Krura Koshtha is ofVata-Kapha predominance and Madhyama Koshtha is of Sama Dosha,which is also called Sadharana Koshtha.3 Some acharyasare of the opinion that Krura Koshtha is constituted by Vata Dosha.
In Vimana Sthana, Acharya Charaka explains Mridu-Darunatwamof Grahani should be assessed by Atura Pariprashna. In Sutra Sthana,on the context of Snehana, he explains a person of Mridu Koshthais 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– 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. Virechanais 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 Shodhanatherapy.
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 twoyamas).
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
· To develop and validate a questionnaire using Ayurvedaparameters, for the clinical evaluation of Koshtha in an individual.
SECONDARY
· To explore the relationship between Koshtha and Prakritiof an individual.
· To explore the relationship between Koshtha and Agniof 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 / PreliminaryPhase
Defining Koshtha andfactors to be considered for its assessment
Ø Literature review
Ø Consensus method withexperts, academicians – via Delphi survey and nominal group technique.
Phase – II: ToolDevelopment and Validation
1. Item generation andresponse scales:
· Using same methods as in preliminary phase.
· Generating the domains pertaining to assess the Koshtha;
· Framing questions and sub questions for the assessment ofeach domain.
2. Selection of Type ofresponse, response scales and formats
· Response for each item will be decided through the samemethods.
· Dichotomous response
· Continuous – Likert’s scale
3. Pre-testing questionnaire:
· Face validity - Expert evaluation
· Content validity - Small sample study (10-30respondents)
· 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 :
Internalconsistency (Homogeneity) - Cronbach’s α
Test- RetestReliability (Stability)
· 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 (Cow’smilk) maybe selected, considering its wide acceptancy and availability. Doublethe quantity of daily consumption of Go Ksheera (Cow’s milk) may begiven at time past Sleshma Kaala; and status of Koshthamay 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 itemsare measuring a common domain.
Phase – 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, Snehapanais 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 Snehaused, and the time taken for the digestion on each day will be strictlymonitored and noted.
â—¦ Assessment of appearance of Samyak Snigdha Lakshanawill 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 Koshthaassessment 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), 416–421. http://doi.org/10.5281/zenodo.3370488
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are indicated for Sodhana Snehapana.
排除标准
- •Patients who are not indicated for Sodhana Snehapana.
- •Patients with comorbidities, critically ill patients.
结局指标
主要结局
Development and validation of Koshtha assessment tool.
时间窗: 22 Months
次要结局
- Correlation of Samyak Snigdha Lakshana with the previously obtained Koshtha assessment value.(28 Months)
