Study of Shadvidha Avekshya Kaala wsr to Madhyebhukta Aushadha Kaala

Phase 3

Completed

Conditions: Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: VIDAGDHAJANYA-AJIRNAM/PITTAJA-AJIRNAM,

Registration Number: CTRI/2021/02/031291

Lead Sponsor: Institute of Teaching and Research in Ayurveda

Brief Summary: **Introduction:** In Ayurveda, more emphasis has been given to *Kaala* with regards to drug administration. According to Acharya Charaka, *Kaala* is the factor which determines the manifestation of desired effects of the administered drug therapy.

**Significance:** To fulfil the objectives like multidimensional usage and quick action of medicines and also to enhance the potency of Ayurveda treatment modality, administration of drugs with regards to *Dina* (different parts of the day), *Atura* (nature of the patient), *Aushadha* (*nirannaadi aushadha kaala*), *Vyadhi* (nature/stage of the disease), *Jirna*-*linga* (stage of the digestion of food) and *Ritu* (nature of the season) is of utmost importance.

**Materials and Methods:** The study will be carried out in two phases- Conceptual study and Clinical study. Clinical study will be started after obtaining clearance from Institutional Ethics Committee. Clinical study: Patients suffering from *Vidagdhajirna* will be divided into two groups by using computer generated randomization chart. *Abhayaadi* *Gutikaa* will be used as a drug and its efficacy given in two different *Aushadha* *Kaalas* will be evaluated.

Group 1 will receive the drug at *madhyebhukta* *kaala* (in the middle of the meal, twice a day) while Group 2 will receive it at *niranna* *kaala* (empty stomach, twice a day).

**Results and Discussion:** Data generated during the above study will be presented in a systemic manner and shall be analyzed statistically.

**Follow up:** After completion of therapy, follow up will be done for 14 days to assess the status of patients. **Adverse effects:** This proposal will be reviewed and approved by Institutional Ethics Committee, I.T.R.A., Jamnagar which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients in the age group between 18 to 60 years.
Patients having classical signs and symptoms of Vidagdhajirna (minimum 3 symptoms).
Patients having chronicity not more than one month.

Exclusion Criteria

Patients having age less than 18 years and more than 60 years.
Patients suffering from any systemic disease which intervenes with the treatment.
Patients having chronicity more than one month.
Patients in which one or more contents of Abhayaadi Gutikaa are contraindicated.
Pregnant and lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of role and importance of Shadvidha Avekshya Kaala in therapeutics in terms of better efficacy of the treatment prescribed.	4 weeks

Secondary Outcome Measures

Name	Time	Method
To improve quality of life	28 days

Trial Locations

Locations (1): Institute of Teaching and Research in Ayurveda
🇮🇳
Jamnagar, GUJARAT, India
Institute of Teaching and Research in Ayurveda
🇮🇳Jamnagar, GUJARAT, India
Sunny Patil
Principal investigator
9664366756
sunnypatil125@gmail.com