| CTRI Number |
CTRI/2022/03/041419 [Registered on: 28/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative drug study between to pistacia lenticus (rumi mastagi) plant gum and levosulpiride drug, to see their effects on patients suffering from diabetes related indigestive problems |
|
Scientific Title of Study
|
Efficacy of Pistacia Lenticus Plant (Rumi Mastagi) in
Comparison to Levosupiride in Patients with Diabetic Gastroparesis A Double Blind
Randomized Control Trial Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRavi kant |
| Designation |
Additional Professor and Head Division of Diabetes and Metabolism |
| Affiliation |
All india institute of medical sciences , rishikesh |
| Address |
Department of internal medicine A BLOCK level 6 AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9870717859 |
| Fax |
|
| Email |
drkantr2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRavi kant |
| Designation |
Additional Professor and Head Division of Diabetes and Metabolism |
| Affiliation |
All india institute of medical sciences , rishikesh |
| Address |
Department of internal medicine A BLOCK level 6 AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9870717859 |
| Fax |
|
| Email |
drkantr2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajaypal Singh |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences , rishikesh |
| Address |
Department of internal medicine A BLOCK level 6 AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7987135606 |
| Fax |
|
| Email |
apsingh97m@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
|
|
Primary Sponsor
|
| Name |
dr ravikant |
| Address |
department of internal medicine
a Block level 6 aiims rishikesh |
| Type of Sponsor |
Other [self] |
|
|
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 Ravikant |
AIIMS Rshikesh |
department of internal medicine ROOM NO 1 2nd floor diabetic OPD AIIMS Rishikesh ,veerbhadra road ,Rishikesh , district Dehradun 249203
Dehradun
UTTARANCHAL |
9870717859
drkantr2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institutional Ethical Committee Registration No. ECR/736/Inst/UK/2015/RR-21 issued under Rule 122DD of the Drugs & Cosmetics Rules 194 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E106||Type 1 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (2) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: pistacia lenticus gum(mastig gum), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: interventional mastig gum will be taken twice daily along with water as per standard guideline mentioned in European medical agency monograph recommondations. | | 2 | Comparator Arm (Non Ayurveda) | | - | LEVOSULPIRIDE | Capsule form (same as interventional drug) of levosulpiride will be used in diabetic gastroparesis at a dose of 25 mg per oral twice a day between two meals along water, for the duration of 8 weeks (same as interventional drug)_ |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all diabetic patients who are between 19 to 65 years of age with not meting exclusion criteria |
|
| ExclusionCriteria |
| Details |
diabetic patients with following conditions will be excluded from study-
1)Patient with PUD.
2)Irritable bowel syndrome.
3)Any known organic gastrointestinal or systemic diseases.
4)Diabetes in pregnancy lactation.
5)History of breast diseases.
6)Abnormalities of the menstrual cycle.
7)Previous abdominal surgery.
8) Mental disorders.
9)The use of drugs interfering with gastrointestinal motility.
10)The above diseases shall be ruled out by appropriate clinical assessment and patient case sheet records.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 improvement or changes in gastric transit time in diabetic gastroparesis time point - 8 weeks
2 improvement in Gastroparesis cardinal symptom index (GCSI) - time point- 8 weeks
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvemnet in Hb1AC level
imrovement in lipid profile
Improvement in general well-being
Postprandial fullness/early satiety |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| This study is a randomised double blind parallel group trial to compare efficacy of pistacia lenticus plant (RUMI MASTAGI) 500mg PO BD and levosupiride 25 mg PO BD in patients with diabetic gastroparesis: a pilot study, that will be conducted in All India Institute Of Medical Sciences , Rishikesh . The expected primary outcome measures will be improvement or changes in gastric transit time (scintigraphy) and Gastroparesis cardinal symptom index (GCSI) after 8 weeks of administration of lenticus gum. The expected secondary outcomes Improvemet in Hb1AC level ,improvement in lipid profile of patient , Improvement in general well being , Postprandial fullness/early satiety after 8 week of ayurvedic medicine.( Mastig gum) | |