FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037529 [Registered on: 25/10/2021] Trial Registered Prospectively
Last Modified On: 24/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To rule out the effect of Vasaghrita in Urdhvag Amlapitta(Hyperacidity)according to Chakradatta 
Scientific Title of Study   Study of Trisutra in Urdhvag Amlapitta and its management by Vasaghrita w.s.r. to Chakradatta 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Yadav 
Designation  PG SCHOLAR 
Affiliation  Mahatma Gandhi Ayurved College Hospital & Research Centre Salod (H) Wardha 
Address  Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Datta Meghe Institute of Medical Sciences Wardha Nagpur Maharashtra India

Wardha
MAHARASHTRA
442004
India 
Phone  7974154869  
Fax    
Email  dy3385640@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Borker 
Designation  PROFESSOR 
Affiliation  Mahatma Gandhi Ayurved College Hospital & Research Centre Salod (H) Wardha 
Address  Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Datta Meghe Institute of Medical Sciences Wardha Nagpur Maharashtra India

Wardha
MAHARASHTRA
442004
India 
Phone  8446127058  
Fax    
Email  preetiborkar1977@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Borker 
Designation  PROFESSOR 
Affiliation  Mahatma Gandhi Ayurved College Hospital & Research Centre Salod (H) Wardha 
Address  Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Datta Meghe Institute of Medical Sciences Wardha Nagpur Maharashtra India

Wardha
MAHARASHTRA
442004
India 
Phone  8446127058  
Fax    
Email  preetiborkar1977@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurved College Hospital & Research Centre Salod (H.) Wardha 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurved College Hospital Research Centre Salod H Wardha 
Address  Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital & Research Centre Salod (H.) Wardha 
Type of Sponsor  Private 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 Deepak Yadav  Mahatma Gandhi Ayurved Hospital and Research Center  Room No 2 First Floor Department of Samhita Siddhant Mahatma Gandhi Ayurved College Hospital & Research Centre Salod (H.) Wardha
Wardha
MAHARASHTRA 		 7974154869

dy3385640@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  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: Urdhavag Amlapitta ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vasaghrita, Reference: (Bhaishajya Ratnavali Slok no. 124) (13 Chapter), Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: 2 visits during treatment each after 7 days and 2 follow up each after 7 days of treatment.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  1 Patient age above 20 yrs. and below 65 yrs.
2 both sexes will be selected.
3 Patient suffering from typical signs and symptoms of Amlapitta
 
 
ExclusionCriteria 
Details  1 Patient age group below 20 yrs. and above 65 yrs. were excluded.
2 Pregnant and lactating mother.
3 Patients suffering from chronic diseases such as diabetes, hypertension, IHD, chemotherapy and major operative procedure etc., were excluded.
4 Irregular patients not providing proper data were excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Vasaghrita in Urdhvag Amlapitta  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Vasaghrita in Urdhvag Amlapitta in all types of Parameters  2 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/10/2021 
Date of Study Completion (India) 31/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   BRIEF SUMMARY ON PURPOSE -

Ayurveda is an ancient science of life that focuses on the primary goal of "Dhatushamyata"1 for living a long and healthy life. Ayurveda offers numerous concepts regarding dhatu balance and illness management, which includes three main pillars (Hetu, Linga, and Aushadha2) that aid in the understanding of disease symptoms and therapy. Hetu as causal causes, Linga as particular symptoms, and Ashudh as medication and illness therapy are the three components of the Trisutra.

BACKGROUND OF TRIAL - 

Literature and Interventional study.

                                                            Study design

                                        

  Literature review of Urdhavags Amlapita                                      Clinical study

                                                     Assessment of patient as per inclusion and exclusion criteria

                                                                                                                 Inform consent

                                                                          Treatment duration 14 days through oral route

                                                                                vasa ghrita 10ml in the morning along with

                                                                                nidanparivarjan and pathyapathya

 

                                                                                  2 visits during treatment each after 7 days

                                                                               2 Follow up after 7 days each after treatment

                                                                                            Generation of statistical data

                                                                                                      Statistical analysis

                                                                                                              Discussion

                                                                                                  Conclusion and Summary

 Sampling procedure:

Simple random sampling.

Sample size (Including sample size calculation): 60 Patients.

Grouping & Posology:

Group

Sample size

Intervention

Dose and Frequency

Anupana

Duration

Follow up

Trial drug

60

Vasaghrita 10 ml

10 ml once a day

Lukewarm water

14 Days

2 visits during treatment each after 7 days and 2 follow up each after 7 days of treatment.

 

Data collection tools and process: -

 From the OPD & IPD of Mahatma Gandhi Ayurved college hospital and research Centre, Salod, Wardha.

Gradations of symptoms.

Sr.no

Sign/Symptoms

Grading

1         

Vanti -

0        absent

1        once/week or less quantity

2        2-3 times/week or moderate

3        > 3 times/week or profuse

2         

Shiroruja,

0         - Absent

1         Occasional

2         Intermittent

3         Continuous affecting routine work

4         

Kar - charandaha,

 

0         Absent

1         Occasional

2         Intermittent

3         Continuous affecting routine work

4         

Sarvangdaha

0 - Absent

1- Occasional

2- Intermittent

3- Continuous affecting routine work

5         

Hridkanthadaha

0 - Absent

1- Occasional

2- Intermittent

3- Continuous affecting routine work

6         

Aruchi

0-      Absent

1-    Occasional

2-    Intermittent

3-       Continuous affecting routine work

7         

Tikta - amlaudgar

0 - Absent

1- Occasional

2- Intermittent

3- Continuous affecting routine work

8         

Kandu,

0 - Absent

1- Occasional

2- Intermittent

3- Continuous affecting routine work

9         

Jvara -

 0– absent

 1- 99Ëš- 100ËšF

 2--101Ëš-103ËšF

 3 - >103ËšF

10    

Mandal

  0 - absent

1        - 1-2mm

  2   - up to 3mm

 3   - up to 5mm

11

Pidaka

0 - skin colour

1 - hyperaemic

2 - red

3 - dark red


FINDINGS -

Primary Outcomes:

We will see the Significant effect of vasa ghrita on Amlapitta,

Secondary Outcomes:

We will see the effect of vasa ghrita on Amlapitta all types of parameters


 
Close