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CTRI Number  CTRI/2025/04/084941 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Study to evaluate the effect of Vasadi Kwath Ghanvati on Urdhawaga Amlapitta and its pharmaceutico analytical standardization.  
Scientific Title of Study   Pharmaceutico analytical standarization of Vasadi Kwath and its modified dosage form i.e. Ghanvati with its clinical evaluation in Urdhawaga Amlapitta 
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 Varun Kumar 
Designation  MD Research Scholar 
Affiliation  State Ayurvedic College and Hospital,Lucknow 
Address  Post Graduate Department of Ras Shastra and Bhaishajya Kalpana, State Ayurvedic College and Hospital,Lucknow

Lucknow
UTTAR PRADESH
226004
India 
Phone  8004666652  
Fax    
Email  godvk1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajeev Narayan Bilas 
Designation  Reader, Post Graduate Department of Ras Shastra and Bhaishajya Kalpana 
Affiliation  State Ayurvedic College and Hospital,Lucknow 
Address  Post Graduate Department of Ras Shastra and Bhaishajya Kalpana, State Ayurvedic College and Hospital,Lucknow

Lucknow
UTTAR PRADESH
226004
India 
Phone  8601447447  
Fax    
Email  rajeevbilas427@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varun Kumar 
Designation  MD Research Scholar 
Affiliation  State Ayurvedic College and Hospital,Lucknow 
Address  Post Graduate Department of Ras Shastra and Bhaishajya Kalpana, State Ayurvedic College and Hospital,Lucknow

Lucknow
UTTAR PRADESH
226004
India 
Phone  8004666652  
Fax    
Email  godvk1994@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic College and Hospital Lucknow,226004,U.P.,India. 
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital Lucknow 
Address  State Ayurvedic College and Hospital Lucknow,226004,U.P.,India. 
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 Varun Kumar  State Ayurvedic College and Hospital Lucknow,226004,U.P.,India.  P.G. Department of Ras shastra and Bhaishajya kalpana,State Ayurvedic College and Hospital Lucknow,226004,U.P.,India.
Lucknow
UTTAR PRADESH 		 8004666652

godvk1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Institutional Ethics Committee,State Ayurvedic college and hospital,Lucknow.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: vasadi kwath ghanvati, Reference: gad nigrah 38/24, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Socio economic status : all
2 Chronicity less than 3 years
3 Those patients who will willingly give written consent to participate in the study will be included in the study.
 
 
ExclusionCriteria 
Details  1 Patients with history of systemic illness like uncontrolled diabetes mellitus and hypertension , thyroidism,cardiac pathology,immunodeficiency disorders like AIDS.
2 Patients with history of parinamshool(gastric ulcer,duodenal ulcer),Annadrava shool , krimiroga, Arbuda.
3 Patients with history of haemetemesis , malena , and anemia.
4 Patients with drug induced Amlapitta.
5 CA stomach.
6 Severe Liver, Gall bladder & Pancreatic disorder
7 Patients with alcohol abuse
8 Patients with Hiatus Hernia 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Sour eructations
2 retrosternal burning
According to Madhav nidan amlapitta adhyaya. 		 before trial
after 15 days
after 30 days
after 45 days
after trial 
 
Secondary Outcome  
Outcome  TimePoints 
1 Indigestion
2 Tiredness without labour
3 Nausea
4 loss of appetite
5 mucus spitting
6 Heavyness of body
According to Madhav nidan amlapitta adhyaya. 		 before trial
after 15 days
after 30 days
after 45 days
after trial 
 
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 
Date of First Enrollment (India)   05/05/2025 
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="0"
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  
Present synopsis entitled " PHARMACEUTICO-ANALYTICAL STANDARIZATION OF VASADI KWATH, and its modified dosage form i.e. GHANVATI with its clinical evaluation in URDHAWAGA AMLAPITTA"
Aim of study  :- To assess the efficacy of Vasadi kwath ghanvati on patients of Urdhwaga Amlapitta.
Objective of study :- 1  To assess the efficacy of Vasadi kwath ghanvati on patients of Urdhwaga Amlapitta.
                                2 To assess the effectiveness of the drugs on selected subjective and objective parameters. 
                                3  To assess the side effect of trial drugs if any.
PLAN OF STUDY 

                              1- Conceptual study

                                  a - literary review

                                  b - drug review

        2 -Pharmaceutical study


Vasadi Kwath will be prepared in accordance with Sharngadhar Samhita where basic preparation of kwath is mentioned and its ghanvati  is made by using the method  as explained in classical texts of ayurveda which will be processed in the Rasa-Shala attached with P.G  department of Rasa Shastra & Bhaishajya Kalpana , State Ayurvedic College & Hospital , Lucknow .



        3 -Analytical study

            a - Organoleptic study

- Color

-Odour

-Texture

-Taste  



b - Physico-chemical study



        4 -Clinical study



CLINICAL STUDY



Sample Source - Patients will be selected from the OPD and IPD of State


Ayurvedic College & Hospital, Lucknow UP. In the present study the age group of patients of both sexes will be taken from 20 to 60 years.



Criteria for diagnosis –

 Patients having classical sign and symptoms of Urdhwaga Amlapitta.


Detailed history will be taken and physical examination will be done as per special proforma.




Dose – patient will be asked to take 2 ghanvati 2 times a day before meal with normal water.



Duration of study – Study will be carried out for 2 months

 

Follow-up – 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 in a single group study will be taken from kayachikitsa OPD.

 

Diet and restrictions – The patients will be strictly advised to have routine diet and avoid aggravating factors recommended in various related authentic literatures.

 

Study interventions – During the period of trial, if patients will suffer   from any other associated or non-associated illness, will be treated by restricted Ayurvedic management if required.



INCLUSION CRITERIA 

    1. Age : 20 - 60 years

2. Sex : Both Male and Female

3. Socio economic status : all

4. Chronicity less than 3 years


5. Those patients who will willingly give written consent to participate in the study will be included in the  study.

ESSENTIAL CRITERIA 

    1. Sour eructations Tiktamlodgaar

    2. retrosternal burning Hritkanthdah

NON ESSENTIAL CRITERIA 

     1. Indigestion Avipak

2. Tiredness without labour klam 

3. Nausea utklesh

4. loss of appetite aruchi 

5. mucus spitting kaph nishthivan

6.  Heavyness of body gaurav

   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 uncontrolled diabetes mellitus and hypertension , thyroidism , cardiac pathology , immuno deficiency disorders like AIDS.


2 Patients with history of parinamshool ( gastric ulcer , duodenal ulcer ) , Annadrava shool , krimiroga ,   Arbuda

3 Patients with history of haemetemesis , malena , and anemia.

4 Patients with drug induced Amlapitta.

5 CA stomach.

6 Severe Liver, Gall bladder & Pancreatic disorder

7 Patients with alcohol abuse

8 Patients with Hiatus Hernia

CRITERIA FOR WITHDRAWAL 

- Personal matters

- Aggravation of complaints

- Inter current illness

- Any other difficulties

 

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 complaint and confirmed by clinical examination before trial drugs.

LABORATORY INVESTIGATIONS

The clinical improvement during and after the trial drug will also be correlated with previous intensity of the signs and symptoms.

The following laboratory investigations , as per requirement , will be carried out in all the selected before and after the treatment -

1 Blood Routine for Hb% , TLC , DLC, ESR/CBC before and after trial 

 2 L.F.T. , K.F.T. before and after trial

 3 Blood Sugar - F.B.S., P.P. (if required),HbA1C ,before and after trial

 4 Stool examination for Ova , Cyst , Occult blood when needed

 5 Endoscopy/Barium meal or Barium swallow if necessary

 6 U.S.G. whole abdomen if required 

 7 T.S.H. tests before and after trial

 8 Lipid Profile before and after trial

Total Effect of the therapy :-

The total effect of therapy of this trial will be grouped as follows-

1 Relieved

2 Improved

3 Unchanged

4 Worsened

 

1 Relieved-

Patients having 76-100 % relief in terms of symptoms.

 No recurrence of disease up to follow up period.

 

2 Improved-

 Patients having improvement between 51-75% in clinical symptoms.

Mild Improvement- Improvement between 51-63.5% in clinical symptoms.

 Moderate Improvement- Improvement between 63.5-75% in clinical symptoms.

 

3 Unchanged -

Patients having improvement less than 50% in terms of clinical symptoms.

Disease may reoccur.

4 Worsened-

Patient having no improvement in terms of clinical response.


Disease may get worsened or symptoms may get increased.
 
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