PHASE 1 – OBSERVATIONAL STUDY

 

RESEARCH QUESTION:

                            Is there any association between doshic imbalance and circadian rhythm alteration among night workers having Amlapitta

HYPOTHESIS

  Null Hypothesis [H01]- There is no association between doshic imbalance and circadian rhythm alteration among night workers having Amlapitta.

                                   Alternative Hypothesis [HA] – There is association between doshic imbalance and circadian rhythm alteration among night workers having Amlapitta.

4.      AIM: To study the association between circadian rhythm alteration and doshic imbalance among night workers having Amlapitta.

 

  Primary Objective

To correlate serum cortisol levels with circadian rhythm alteration and doshic imbalance as a biomarker of physiological stress.

Secondary Objectives

• To assess the distribution of chronotypes (morning, intermediate, evening types) among night workers using the Morningness-Eveningness Questionnaire (MEQ).[i]
• To identify the predominant doshic imbalance (Vata, Pitta, Kapha, or their combinations) associated with circadian rhythm disturbances.
• To explore the relationship between the degree of circadian misalignment and the severity of doshic imbalance.

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[i] https://www.med.upenn.edu/cbti/assets/user-content/documents/Morningness-Eveningness%20Questionnaire.pdf

PHASE 2 – CLINICAL STUDY

                           RESEARCH QUESTION:

Is there any difference in efficacy of Yavadi Kwatha and Amlapitta Mishran in management of Amlapitta among night workers?

HYPOTHESIS:                              

      Null Hypothesis [H01]:

There is no difference in the efficacy of Yavadi Kwatha and Amlapitta Mishran in managing Amlapitta in night workers.

          Alternate Hypothesis [HA]:

There is a difference in the efficacy of Yavadi Kwatha and Amlapitta Mishran in managing Amlapitta in night workers.

                                             AIM:

To compare difference in the efficacy of Yavadi Kwatha and Amlapitta Mishran in managing Amlapitta among night workers.

                      OBJECTIVES:

Primary Objective:

   To evaluate efficacy of Yavadi Kwatha and Amlapitta Mishran Suspension in improvement of Amlapitta Symptom Rating Scale from baseline to day 30.

Secondary Objectives                                      

To evaluate efficacy of Yavadi Kwatha and Amlapitta Mishran Suspension in improvement of Post Prandial Distress Syndrome (PPDS) score from baseline to day 30.

 To evaluate efficacy of Yavadi Kwatha and Amlapitta Mishran Suspension in improvement of Epigastric Pain Syndrome (EPS) score from baseline to day 30.

To assess the safety of Yavadi Kwatha and Amlapitta Mishran Suspension on GERD Scale score from baseline to day 30.

ASSESSMENT CRITERIA 

Amlapitta Symptom Ratings Scale: Scale of 0-21

Functional Dyspepsia is divided into Postprandial Distress Syndrome (PPDS) and Epigastric Pain Syndrome (EPS). Criteria for PPDS and EPS will be recorded on a Likert scale to see improvement in the symptoms at the end of treatment.

Postprandial Distress Syndrome (PPDS) Diagnostic Criteria score:

     Bothersome postprandial fullness severe enough to impact on usual activities) – Likert scale of 1 (very mild) to 5 (very severe).

     Bothersome early satiation severe enough to prevent finishing a regular-size meal) – Likert scale of 1 (very mild) to 5 (very severe).

Epigastric Pain Syndrome (EPS) Diagnostic criteria score:

  Bothersome epigastric pain severe enough to impact on usual activities) - Likert scale of 1 (very mild) to 5 (very severe).

   Bothersome epigastric burning severe enough to impact on usual activities) - Likert scale of 1 (very mild) to 5 (very severe)

GERD Health Related Quality of Life (GERD HRQL) Questionnaire