A Study To Evaluate The Effectiveness Of Patoladi Yoga Ghan Vati and Drakshadi Gutika in cases of Urdhwaga Amlapitta wsr to GERD

Phase 2/3

Not yet recruiting

Conditions: Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,

Registration Number: CTRI/2023/04/051876

Lead Sponsor: State Ayurvedic College and Hospital Lucknow

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 â€“ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. tikta Amla Udgaar - Sour eructation	0Week, 2nd Week, 4th week, 6th week
2. Hrita Kantha Daaha- Retrosternal burning	0Week, 2nd Week, 4th week, 6th week

Secondary Outcome Measures

Name	Time	Method
1. Avipaaka Indigestion	2. Klama - Tiredness without excertion

Trial Locations

Locations (1): State Ayurvedic College & Hospital
🇮🇳
Lucknow, UTTAR PRADESH, India
State Ayurvedic College & Hospital
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Amit Kumar Rajpoot
Principal investigator
8840528635
dr.amitrajpoot5@gmail.com