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CTRI Number  CTRI/2023/04/051876 [Registered on: 24/04/2023] Trial Registered Prospectively
Last Modified On: 21/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study To Evaluate The Effectiveness Of Patoladi Yoga Ghan Vati and Drakshadi Gutika in cases of Urdhwaga Amlapitta wsr to GERD  
Scientific Title of Study   A Clinical Comparative Study To Evaluate The Effectiveness Of Patoladi Yoga Ghan Vati And Drakshadi Gutika in cases of Urdhwaga Amlapitta wsr to GERD  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Kumar Rajpoot 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital
Tulsidas Marg Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India 
Phone  8858281219  
Fax    
Email  dr.amitrajpoot5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shachi Srivastava 
Designation  Reader 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital
Tulsidas Marg, Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India 
Phone  9415063998  
Fax    
Email  drshachi09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Kumar Rajpoot 
Designation  Research Scholar 
Affiliation  State Ayurvedic College and Hospital Lucknow 
Address  Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital
Tulsidas Marg Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India 
Phone  8858281219  
Fax    
Email  dr.amitrajpoot5@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital Lucknow  
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital Lucknow  
Address  State Ayurvedic College and Hospital ,Lucknow 226003 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Kumar Rajpoot  State Ayurvedic College & Hospital  Department of Kayachikitsa, State Ayurvedic College and Hospital Lucknow
Lucknow
UTTAR PRADESH 		 8840528635

dr.amitrajpoot5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Drakshadi Gutika , Reference: Yoga Ratnakar Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Plain water), Additional Information: -2 Drakshadi Gutika (5gm each) with plain water before meals twice in a day for 45 days with follow up of 15 days.
2Intervention ArmDrugClassical(1) Medicine Name: Patoladi yoga ghan vati, Reference: Bhava Prakaasha Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -2 Gutika (2 gm each) twice in a day with plain water half an hour before meal for 45 days.
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ESSENTIAL CRITERIA:
1. tikta Amla Udgaar - Sour eructation
2. Hrita Kantha Daaha- Retrosternal burning

NON-ESSENTIALCRITERIA:
1. Avipaaka Indigestion
2. Klama - Tiredness without excertion
3. Utakalesha- Nausea
4. gorava- Heaviness of body
5. Aruchi- Anorexia (Loss of appetite)

Patients of Urdhwaga Amlapitta having all essential criteria with or without
non-essential criteria will be selected for the clinical trial. 
 
ExclusionCriteria 
Details  The following patients will not be selected for the plan of study: -
1. Patients with history of systemic illness like hypertension, thyroid disorder,
cardiac disease.
2. Patients with history of gastric ulcer, duodenal ulcer.
3. Patient with history of haematemesis, melena and anemia.
4. Patient with drug induced Amlapitta.
5. CA Stomach 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. tikta Amla Udgaar - Sour eructation
2. Hrita Kantha Daaha- Retrosternal burning
 		 0Week, 2nd Week, 4th week, 6th week  
 
Secondary Outcome  
Outcome  TimePoints 
1. Avipaaka Indigestion
2. Klama - Tiredness without excertion
3. Utakalesha- Nausea
4. gorava- Heaviness of body
5. Aruchi- Anorexia (Loss of appetite) 		 0Week, 2nd Week, 4th week, 6th week  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   24/04/2023 
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   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.amitrajpoot5@gmail.com].

  6. For how long will this data be available start date provided 10-01-2023 and end date provided 10-01-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
PLAN OF STUDY
SELECTION OF PATIENT:
For the purpose of clinical trial, the patients of Urdhwaga Amlapitta will be
selected from OPD and IPD of State Ayurvedic College and Hospital, Lucknow
and referred patients from other clinics and hospital will also be registered. A
careful clinical examination and necessary investigation will be performed as per
proforma. After the diagnosis is established, the patient will be included for the
trial.
INCLUSION CRITERIA:
1. Age: 16 – 60 years
2. Sex: both Male and female
3. Socio economic status: all
4. Chronicity less than 3 yrs.
5. Those patients who are willing to give written consent to participate in the
study will be included in the study.

ESSENTIAL CRITERIA:
1. tikta Amla Udgaar - Sour eructation
2.  Hrita Kantha Daaha- Retrosternal burning

NON-ESSENTIALCRITERIA:
1. Avipaaka Indigestion
2. Klama - Tiredness without excertion
3. Utakalesha- Nausea
4. gorava- Heaviness of body
5. Aruchi- Anorexia (Loss of appetite)
Patients of Urdhwaga Amlapitta having all essential criteria with or without
non-essential criteria will be selected for the clinical trial.

EXCLUSION CRITERIA:
The following patients will not be selected for the plan of study: -
1. Patients with history of systemic illness like hypertension, thyroid disorder,
cardiac disease.
2. Patients with history of gastric ulcer, duodenal ulcer.
3. Patient with history of haematemesis, melena and anemia.
4. Patient with drug induced Amlapitta.
5. CA Stomach

CRITARIA FOR WITHDRAWAL:-
- Personal matters
- Aggravation of complaints
- Inter current illness
- Any other difficulties

Type of Study :Phase II, Randomised Parallel Study
Period of Study: Total duration of clinical trial will be of 45 days.

Follow up Period: Follow up studies of all registered patients will be done at
fortnight interval for a period of 45 days with drug trial and next 15 days without
drug to assess the condition of patient and to observe any side effect.

Sample Size: Minimum 60 patients of Urdhwaga Amlapitta from OPD and IPD
of State Ayurvedic College & Hospital and referred cases of other hospitals will
be selected with approximately 10% drop out.

Grouping of Patients: All the selected patients of urdhwaga amlapitta will be
divided into two groups
Group A: In this group patient will be treated with Patoladi yoga ghan vati in the
doses of 2 Gutika (2 gm each) twice in a day with plain water half an hour before
meal for 45 days.
Group B: In this group patient will be treated with Drakshadi Gutika in the doses
of 2 Gutika (5gm each) twice in a day with plain water half an hour before meal
for 45 days.

Criteria for assessment-
All the signs and symptoms are graded 0, 1, 2, 3 or 0, +, ++,+++(Nil, Mild,
Moderate, Severe) on the basis of intensity and severity by the patients on
complained and confirmed by clinical examination before trial drugs.
The clinical improvement during and after the trial drug will also be
correlated with previous intensity of the signs and symptoms.
 
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