Pharmaceutico analytical standarization of Vasadi Kwath and its modified dosage form i.e. Ghanvati with its clinical evaluation in Urdhawaga Amlapitta

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.