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A Clinical study to evaluate the effect of ASFP001/21 and SMXP001/22 on improvement in quality of life in healthy volunteers with mild to moderate functional dyspepsia symptoms.

A randomized, double blinded, placebo controlled comparative study to evaluate the effect of ASFP001/21 and SMXP001/22 on improvement in quality of life in healthy volunteers with mild to moderate functional dyspepsia symptoms.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044075
Enrollment
93
Registered
2022-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ASFP001/21: Oral administration of two doses of ASFP001/21 250mg capsules everyday for 14 days Intervention2: SMXP001/22: Oral administration of two doses of SMXP001/22 250mg capsules

Sponsors

Akay Natural Ingredients Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Fulfilling Rome IV diagnostic criteria for functional dyspepsia 2.Female subjects who are non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator 3. Must be willing and able to give informed consent and comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1.History of peptic ulcer, gastro oesophageal reflux disease, gastro intestinal surgery or any other clinically significant gastro intestinal disease, gastrointestinal bleeding, mechanical obstruction, perforation, gastrointestinal cancer. 2.Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract 3.History of psychiatric illness 4.History of congestive heart failure or uncontrolled hypertension 5.Subjects with abnormal haematological or biochemical parameters

Design outcomes

Primary

MeasureTime frame
Improvement in quality of life in mild to moderate functional dyspepsia symptomsTimepoint: Day 0, Day 2, Day 3, Day 7 and Day 14—

Secondary

MeasureTime frame
Change in cognitive functionsTimepoint: Day 0 and Day 14;Change in Gastro Intestinal SymptomsTimepoint: Day 0, Day 2, Day 3, Day 7 and Day 14;Change in gut microbiotaTimepoint: Day 0 and Day 14—

Countries

India

Contacts

Public ContactJestin V Thomas

Leads Clinical Research and Bio Services Private Limited

jestin.leadsclinbio@gmail.com9845125293

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026