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

Phase 4

Not yet recruiting

• Conditions: 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,

• Registration Number: CTRI/2022/03/041419
• Lead Sponsor: dr ravikant

Brief Summary

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|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)

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-21
• Study Start: 2022-04-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

all diabetic patients who are between 19 to 65 years of age with not meting exclusion criteria.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 improvement or changes in gastric transit time in diabetic gastroparesis time point - 8 weeks	8 weeks
2 improvement in Gastroparesis cardinal symptom index (GCSI) - time point- 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
Improvemnet in Hb1AC level	imrovement in lipid profile

Trial Locations

Locations (1)

AIIMS Rshikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

AIIMS Rshikesh

🇮🇳Dehradun, UTTARANCHAL, India

Dr Ravikant

Principal investigator

9870717859

drkantr2006@gmail.com