| CTRI Number |
CTRI/2025/03/082180 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on Guduchyadi Gana to see the effect in patients having symptoms related to Ama which are explained in classical text Ashtanga Hridaya |
|
Scientific Title of Study
|
Conceptual and applied study of Ashtanga Hridaya Sutra Sthana 11-15 Adhyaya w.s.r. to effect of Guduchyadi Gana on Ama Lakshana. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Buddhe Pallavi Janardhan |
| Designation |
MD 2nd year Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar. |
| Address |
Department of Basic Principles, 3rd Floor, Institute of Teaching and Research in Ayurveda (Institute of National Importance), Ministry of Ayush, Government of India, Jamnagar - 361008.
Jamnagar
GUJARAT
361008
India |
| Phone |
09284049979 |
| Fax |
|
| Email |
buddhepallavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suhag D Raval |
| Designation |
Lecturer |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar. |
| Address |
Department of Basic Principles, 3rd Floor, Institute of Teaching and Research in Ayurveda (Institute of National Importance), Ministry of Ayush, Government of India, Jamnagar - 361008.
Jamnagar
GUJARAT
361008
India |
| Phone |
9784837835 |
| Fax |
|
| Email |
suhagdraval@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suhag D Raval |
| Designation |
Lecturer |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar. |
| Address |
Department of Basic Principles, 3rd Floor, Institute of Teaching and Research in Ayurveda (Institute of National Importance), Ministry of Ayush, Government of India, Jamnagar - 361008.
Jamnagar
GUJARAT
361008
India |
| Phone |
9784837835 |
| Fax |
|
| Email |
suhagdraval@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda (INI) Ministry of Ayush opposite of city B division police station gurudwara road jamnagar gujrat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda (INI) Ministry of Ayush opposite of city B division police station gurudwara road jamnagar gujrat 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 |
| Dr Pallavi Janardhan Buddhe |
PG hospital Institute of teaching and research in ayurveda Jamnagar Gujrat |
OPD No:9 Department of Basic Principles institute of teaching and research in ayurveda Jamnagar, opposite city B division police station, Gurudwara road , Jamnagar, Gujrat 361008
Jamnagar
GUJARAT |
09284049979
buddhepallavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 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:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: AMADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: suji capsules , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Ghanavati, Reference: Ashtanga Hrdaya of Vagabhatta, Sutrasthana Shodhanadi Gana Sangraha Adhyaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having minimum 4 signs or symptoms of Ama.
2.The patients diagnosed with other disease having sign or symptoms of Ama will be included in the study.
3.Age between 18 to 50 years.
4.Chronicity less than 3 months
|
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years and more than 50 years.
2.Patients suffering from any other disease which intervenes with the treatment.
3.Patients having major systemic disease like cardiac disease, ulcerative colitis, chronic kidney disease, diabetes mellitus, hypertension, thyroid disorders etc.
4.Pregnant women and Lactating mothers.
5.Patients taking the course of any allopathic or other medicine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modification in subjective criteria in the form of questionnaire with answer in grades like 0,1,2,3 of Ama Lakshana according to severity |
assess after 15 days of course |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvment in the clinical condition of Ama Lakshana.
2.Improvment in the quality of Life. |
20 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to access the effect of guduchyadi gana in the form of Ghanavati in the patients having ama lakshana. Participants will be asked questions from IEC approved questionnaire for Ama Lakshana maid by Dr Suresh Panchal MD scholar of RNVV department ITRA, Jamnagar. If participants shows minimum 4 sign or symptoms of Ama mentioned in Ashtanga Hridaya sutra sthana 13th Adhyaya will be enrolled in the study .Total 100 participants will be enroll in study and will be divided into two groups 50 participants each. One group i.e. trail group will receive Guduchyadi Ghanavati with dose of 500mg 2 Ghanavati in Pragbhakta Kala with Ushnodaka for 15 days. Other group will receive placebo in the form of roasted suji capsules with dose of 500mg 2 capsules in Pragbhakta Kala with Ushnodaka for 15 days. As there is no data available of other drug or formulation showing similar properties as Guduchyadi Gana placebo in the form of Roasted suji capsules are chose to compare trail drug. Both the groups will receive same pathya apathya chart and will be counselled about it. The results will be assessed and end of treatment and improvement or modifications related to Ama Lakshana will be assessed using same questionnaire. Results and discussion will done based on data collected. |