| CTRI Number |
CTRI/2020/02/023224 [Registered on: 10/02/2020] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out the effect and safety of Amlapitta Mishran Suspension in patients with gastritis (stomach inflammation). |
|
Scientific Title of Study
|
A prospective, single centre, open label, single arm study to Evaluate the Efficacy and Safety of Amlapitta Mishran Suspension in Participants with Endoscopic Gastritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Lahoti |
| Designation |
Hepatologist and Gastroenterologist |
| Affiliation |
Suyash Hospital A unit of Suyash Institute of Medical Science Pvt. Ltd. |
| Address |
Kota Gudhiyari Road
Behind Hotel Piccadily
Raipur
Raipur
CHHATTISGARH
492 001
India |
| Phone |
9826851120 |
| Fax |
|
| Email |
manojlahoti24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Chawda |
| Designation |
Senior Manager Medical Services |
| Affiliation |
Shree Dhootapapeshwar Limited |
| Address |
135 Nanubhai Desai Road Khetwadi
Mumbai
MAHARASHTRA
400 004
India |
| Phone |
9821482290 |
| Fax |
|
| Email |
mbc@solumiks.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Chawda |
| Designation |
Senior Manager Medical Services |
| Affiliation |
Shree Dhootapapeshwar Limited |
| Address |
135 Nanubhai Desai Road Khetwadi
Osmanabad
MAHARASHTRA
400 004
India |
| Phone |
9821482290 |
| Fax |
|
| Email |
mbc@solumiks.in |
|
|
Source of Monetary or Material Support
|
| Shree Dhootapapeshwar Limited |
|
|
Primary Sponsor
|
| Name |
Shree Dhootapapeshwar Limited |
| Address |
135 Nanubhai Desai Road Khetwadi Mumbai 400 004 |
| Type of Sponsor |
Other [Ayurved] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Lahoti |
Suyash Hospital A unit of Suyash Institute of Medical Science Pvt. Ltd. |
Kota, Gudhiyari Road, Behind Hotel Piccadily, Raipur - 492 001.
Raipur
CHHATTISGARH |
09826851120
manojlahoti24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Shri Ganesh Vinayak Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K297||Gastritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amlapitta Mishran Suspension |
Amlapitta Mishran 15 ml suspension orally before meals twice daily for 30 days.
Ayurved Proprietary Medicine containing Shouktik Bhasma (Processed Shell) and herbs like Vasa (Adhatoda vasica), Guduchi (Tinospora cordifolia), Parpata (Fumaria indica), Nimba (Azadirachta indica), Kiratatikta (Swertia chirata), Bhrungaraja (Eclipta alba), Patola (Trichosanthes dioica), Yashti (Glycyrrhiza glabra),
Haritaki (Terminalia chebula),Bibhitaka (Terminalia belerica) and
Amalaki (Emblica officinalis)
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of endoscopic gastritis, as diagnosed by the Sydney classification.
2. Participants with normal electrocardiogram (ECG) report.
3. Participants willing to give written informed consent.
4. Participants willing to follow up.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women.
2.Participants who have previously received Amlapitta Mishran Suspension.
3.Participants with documented H pylori infection.
4.Participants with psychiatric disorders including eating disorders.
5.Participants with chronic degenerative diseases including uncontrolled hepatic, renal or endocrine diseases (except diabetes controlled by oral hypoglycaemic agents or controlled hypothyroidism), malabsorption or chronic diarrhoea, history of seizures or epilepsy, gastric surgery or participants with oncological diseases.
6.Participants with previous allergic reactions to any components of Amlapitta Mishran Suspension.
7.Participants who have contraindications to undergo endoscopy.
8.Participants with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy).
9.Participants with oesophageal varix (varices)
10.Participants with malignant neoplasm of gastrointestinal tract.
11.Participants with thrombosis or administered with anti-thrombotic drugs.
12.Participants with coagulation disorders
13.Participants administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 1 weeks.
14.Participants who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment.
15.Participants taking other investigational drugs within 30 days prior to the study.
16.Participants with Zollinger-Ellison syndrome
17.Participants with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
18.Participants with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.
19.Participants with laboratory parameters of Liver function test more than 1.5 times the upper limit of normal or detected any time during the study period will lead to exclusion of the participant from the study.
20.Participants with Serum Creatinine more than 1.5 mg/dl detected any time during the study period will lead to exclusion of the participant from the study.
21.History of life threatening cardiovascular and /or neurological event in the past one year.
22.Participants with history of alcohol or drug abuse, bleeding disorder.
23.Participants having any severe active infectious disease requiring hospitalization.
24.Participants who have taken study drug or any oral herbal medication in the past 4 weeks.
25.Participants with history of severe allergy or anaphylactic reaction.
26.Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
27.Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
28.History of HIV or any immune deficient conditions.
29.Participants that investigators consider ineligible for this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of participants showing improvement in endoscopic gastritis. |
Baseline and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Percentage of participants showing improvement of Amlapitta symptom rating scale.
2. Percentage of participants showing improvement in Postprandial Distress Syndrome symptom scale.
3. Percentage of participants showing improvement in Epigastric Pain Syndrome symptom scale. |
Baseline, Day 15 and Day 30 [Every 2 weeks] |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amlapitta Mishran Suspension is a marketed Ayurvedic Proprietary Medicine prescribed by Ayurved Practitioners across India for the management of acid peptic Disorders. Amlapitta Mishran Suspension is documented for its anti-ulcer effect in experimental model of indomethacin induced gastric ulcers in rats. The ingredients like Vasa (Adhatoda vasica), Guduchi (Tinospora cordifolia), Kiratatikta (Swertia chirata), Nimba (Azadirachta indica), Patola (Trichosanthes dioica), Yashti (Glycyrrhiza glabra) in Amlapitta Mishran Suspension are documented for their anti-ulcer effect. Bhrungaraja (Eclipta alba), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica) and Amalaki (Emblica officinalis) possess gastroprotective activity. Shouktik (Muktashukti) Bhasma (Processed Seashell) has acid neutralising effect and in experimental model is documented for its anti-ulcer activity. Keeping in mind the healing potential of the components of Amlapitta Mishran Suspension this study was planned to evaluate its potential in participants with endoscopic gastritis. Additionally, it will also be evaluated on parameters like Amlapitta symptom rating scale, Post Prandial Distress Syndrome (PPDS) score, Epigastric Pain Syndrome (EPS) score from baseline to day 15 and 30 days. Its safety will be assessed on clinical and laboratory parameters (CBC, LFT and RFT), physical examinations and vital signs (body temperature, pulse) from baseline to day 15 and 30 days. The dosage of Amlapitta Mishran Suspension will be 15 ml orally before meals twice daily for 30 days.
|