| CTRI Number |
CTRI/2021/02/031291 [Registered on: 15/02/2021] Trial Registered Prospectively |
| Last Modified On: |
25/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Shadvidha Avekshya Kaala wsr to Madhyebhukta Aushadha Kaala |
|
Scientific Title of Study
|
Conceptual and Applied Study of Shadvidha Avekshya Kaala wsr to Madhyebhukta Aushadha Kaala |
| Trial Acronym |
SAK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunny Patil |
| Designation |
PhD (Ayu) scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Room no 305, Department of Basic Principles
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Room 305, Department of Basic Principles
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
sunnypatil125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AS Baghel |
| Designation |
Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Room no 310, Department of Basic Principles
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Room 310, Department of Basic Principles
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
asbaghel2001@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AS Baghel |
| Designation |
Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Room No310, Department of Basic Principles
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Room 310, Department of Basic Principles
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Junagadh
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
asbaghel2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda
Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda
Jamnagar 361008
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunny Patil |
Institute of Teaching and Research in Ayurveda |
OPD no 11, Department of Basic Principle, Institute of Teaching and Research in Ayurveda
Jamnagar 361008
Jamnagar
GUJARAT |
9664366756
sunnypatil125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Teaching and Research in Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: VIDAGDHAJANYA-AJIRNAM/PITTAJA-AJIRNAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abhayaadi Gutikaa |
2 Gutikaa of 1gm each, twice a day Orallly at Madhyebhukta Kaala (in the middle of the meal, twice a day) with Jala for 14 Days
|
| Intervention |
Abhayaadi Gutikaa |
Abhayaadi Gutikaa
2 Gutikaa of 1gm each, twice a day Orally at Niranna Kaala (empty stomach, twice a day) with Jala for 14 Days
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishment of role and importance of Shadvidha Avekshya Kaala in therapeutics in terms of better efficacy of the treatment prescribed. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve quality of life |
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "148"
Final Enrollment numbers achieved (India)="148" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/02/2021 |
| Date of Study Completion (India) |
02/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/05/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Indigestion-induced hyperacidity (Vidagdhajirna) treated with Ayurveda Shamana therapy: a single case study
Journal of Indian System of Medicine
ISSN No.
P-2320-4419; E-2455-5029
Vol. 10, Issue. 4
December-2022
Page 265-270 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |