| CTRI Number |
CTRI/2025/09/094481 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An ayurvedic treatment to check the effect of powder of giloy in Acidity disease |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE UPASHAYATMAKA EFFECT OF GUDUCHI SATVA IN URDVAGA AMLAPITTA OR GERD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Angadi |
| Designation |
BAMS |
| Affiliation |
Alvas Ayurvedic Medical College and Hospital |
| Address |
Alvas ayurvedic medical college and Hospital, Vidyagiri Mooodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
08762308239 |
| Fax |
|
| Email |
poojaangadi1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Jain |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurvedic Medical College and Hospital |
| Address |
Alvas ayurvedic medical college and Hospital, Vidyagiri Moodubidire, Dakshina kannada, Karnataka 574227
Alvas ayurvedic medical college and Hospital, Vidyagiri Moodubidire, Dakshina kannada, Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9901327241 |
| Fax |
|
| Email |
drprashanthjain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Angadi |
| Designation |
BAMS |
| Affiliation |
Alvas Ayurvedic Medical College and Hospital |
| Address |
Alvas ayurvedic medical college and Hospital, Vidyagiri Mooodubidire
KARNATAKA
574227
India |
| Phone |
08762308239 |
| Fax |
|
| Email |
poojaangadi1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurvedic medical college and Hospital Dakshina kannada, Karnataka, India 574227 |
| Alvas Ayurvedic medical college and hospital,Dakshina kannada, Karnataka, India 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Angadi |
| Address |
Dept of PG studies in RNVV, Alvas Ayurvedic Medical college, Vidyagiri, Moodubiri 574227 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Pooja Angadi |
Alvas Ayurvedic Medical College and Hospital |
Dept of PG studies in RNVV, Alvas Ayurvedic Medical college, Vidyagiri, Moodubiri 574227
Dakshina Kannada
KARNATAKA |
08762308239
poojaangadi1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, (2) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Satva, Reference: Yogaratnakara, Purvarda, Guduchi Satvaguna Adhaya sloka no 1, Route: Oral, Dosage Form: Sattva, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient who are willing to participate
2) Patient between 16-60 years of age irrespective of gender, religion, etc
3) Subjects having classical symptoms of Urdvaga Amlapitta/GERD |
|
| ExclusionCriteria |
| Details |
1) Pregnant women
2) Patient is diagnosed with CA esophagus
3) Patient with the history of Hematemesis, Melena
4) Patient with peptic ulcer
5) Patient with other systemic disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Upashayatmaka effect of Guduchi satva in Urdavaga Amlapitta/GERD |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Hetu Viparita, Vyadhi Viparita and Ubhaya Viparita effect of Guduchi satva in urdavaga amlapitta/GERD |
7days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Amlapitta is the most common disease whic is characterised by Avipaka, klama ,utklesha, tikta amla
udgara ,Hrith kanta daha are the leading manifestation of Urdvaga amlapitta which simulates symptoms of GERD. Virudda ahara, dusta ahara,
amla, Vidahi ahara and Pitta prakopi panaannaboji are doshaprakopaka hetu responsible for manifestation of Urdvaga
amlapitta.Upashaya
creates a pavement for the path of thinking that Ahara, Vihara and Oushadha
which relieves the Lakshanas of
any Vyadhi. Amlapitta is
Pitta pradhana Tridoshaja Vikara ,the formulation Guduchi satva possess the properties like Madura
tikta
rasa, Laghu guna, Sheeta virya, Pittashamaka
and Tridoshahara .Hence present study is undertaken
to evaluate the Upashayatmaka effect of Guduchi Satva in the management of Udrvaga Amlapitta/GERD Hypothesis: H0- There
is no statistical significant effect of Guduchi Satva
in Urdvaga Amlapitta. H1- There
is a statistical significant effect of Guduchi Satva
in Urdvaga Amlapitta. Sample Size: 40 Study Design Clinical study Minimum
of 40 Subjects suffering from Amlapitta will be selected from OPD & IPD of Alvas
Ayurveda Hospital and special camps and other referrals.
|