| CTRI Number |
CTRI/2022/05/042670 [Registered on: 19/05/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use Of Amlapitta Mishran suspension in treatment of Amlapitta (Hyperacidity) |
|
Scientific Title of Study
|
A Prospective, Multi Centre, Open label, Single arm Study to Evaluate the Efficacy and Safety of Amlapitta Mishran Suspension in Participants with Amlapitta (Symptomatic 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 Reetu Sharma |
| Designation |
(BAMS, MD), Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana
National Institute of Ayurveda
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302 002
India |
| Phone |
07597061958 |
| Fax |
|
| Email |
drreetusharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reetu Sharma |
| Designation |
(BAMS, MD), Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana
National Institute of Ayurveda
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
RAJASTHAN
302 002
India |
| Phone |
07597061958 |
| Fax |
|
| Email |
drreetusharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balkrishan Sevatkar |
| Designation |
Associate Professor BAMS, MD, PhD, DYNP |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana
National Institute of Ayurveda
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302 002
India |
| Phone |
9352311105 |
| Fax |
|
| Email |
drbks6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Healthcare till the duration of study (8 months)at site National Institute of Ayurveda (DENOVO), Near Jorawar Singh Gate, Madho vilas Palace, Amer road, Jaipur, Rajasthan |
|
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Primary Sponsor
|
| Name |
Shree Dhootapapeshwar Limited |
| Address |
195, Nanubhai Desai Road, Khetawadi, Mumbai 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Anaya Pathrikar |
Ayurvidya Prasarak Mandal’s Seth R.V. (Ayurvedic Hospital) |
Ayurvidya Prasarak Mandal’s Seth R.V. (Ayurvedic Hospital)
Near Sion Railway Station, Sion (E), Mumbai 400 022.
Jaipur
RAJASTHAN |
9870214595
anayapathrikar@gmail.com |
| Sevatkar Balkrishan |
National Institute of Ayurveda |
Department of Roga Nidana Evum Vikriti Vigyana
National Institute of Ayurveda, Jaipur, Rajasthan- 302
Jaipur
RAJASTHAN |
9352311105
drbks6@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ayurvidya Prasarak mandal APMs Institutional ethics committee |
Approved |
| Institutional Ethics Committee National Institute of Ayurveda (DENOVO) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K297||Gastritis, unspecified. Ayurveda Condition: Amlapitta (Symptomatic Gastritis), (2) ICD-10 Condition:K297||Gastritis, unspecified. Ayurveda Condition: Amlapitta (Symptomatic Gastritis), (3) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: Amlapitta (Symptomatic Gastritis), |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Amlapitta Mishran Suspension, Reference: NA, Route: Oral, Dosage Form: Dravaka, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of either sex in the age group of 18-65 years.
2.Presence of Amlapitta (symptomatic gastritis), as diagnosed by the Amlapitta Symptom Rating Scale Score ≥ 5 [with Tikta-Amla Udgaar (Sour and bitter belching) and Hrit-Kantha Daha (Burning Sensation) Score ≥ 1].
3.Participants with normal Electrocardiogram (ECG) report.
4.Participants willing to give written informed consent.
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 with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy).
8.Participants with history of oesophageal varix (varices)
9.Participants with history of malignant neoplasm of gastrointestinal tract.
10.Participants with history of thrombosis or administered with anti-thrombotic drugs.
11.Participants with coagulation disorders
12.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.
13.Participants who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment.
14.Participants taking other investigational drugs within 30 days prior to the study.
15.Participants with history of Zollinger-Ellison syndrome
16.Participants with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
17.Participants with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.
18.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.
19.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
20.History of life threatening cardiovascular and /or neurological event in the past one year.
21.Participants with history of alcohol or drug abuse, bleeding disorder.
22.Participants having any severe active infectious disease requiring hospitalization.
23.Participants who have taken test medication or any oral herbal medication in the past 4 weeks.
24.Participants with history of severe allergy or anaphylactic reaction.
25.Participants who cannot give valid consent such as mentally retarded, unconscious participants and psychiatric illness.
26.Known history of positive screening result for hepatitis B and/or Hepatitis C virus.
27.History of HIV or any immune deficient conditiOns. |
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Amlapitta Symptom Rating Scale Score from baseline to Day 14. |
Amlapitta Symptom Rating Scale Score from baseline to Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Post Prandial Distress Syndrome (PPDS) score from baseline to Day 14.
2.To evaluate efficacy of Amlapitta Mishran Suspension in improvement of Epigastric Pain Syndrome (EPS) score from baseline to Day 14.
3.To assess the safety of drug on any adverse events encountered during the trial period at Day 14.
|
from baseline to Day 14. |
|
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Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/05/2022 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Functional Dyspepsia is divided into Postprandial Distress Syndrome (PPDS) and Epigastric Pain Syndrome (EPS). The broad term functional dyspepsia comprises participants from the diagnostic categories of PDS, which is characterized by meal-induced dyspeptic symptoms; EPS, which refers to epigastric pain or epigastric burning that does not occur exclusively postprandially, can occur during fasting, and can be even improved by meal ingestion, and overlapping PDS and EPS, which is characterized by meal-induced dyspeptic symptoms and epigastric pain or burning [3]. Modern medicine offers may drugs / medicaments for the management of Acid Peptic Disorders like gastritis, but their safety may be a cause of concern. Thus, there is need for a new drug with lower side effect profile and good efficacy. Ayurved the ancient Indian system of medicines is a rich database of herbal, mineral and animal origin raw materials / ingredients for the management of acid peptic disorders. Amlapitta is the nearest correlate to acid peptic disorders mainly gastritis and many Ayurved ingredients are extensively studied and documented for their acid neutralising, cytoprotective and ulcer healing potential. Therefore, the current study is planned to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with symptomatic gastritis. |