CTRI Number	CTRI/2020/11/029320 [Registered on: 24/11/2020] Trial Registered Prospectively
Last Modified On:	17/09/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Nutraceutical
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	Efficacy of CL18100F4 to relieve constipation and to improve bowel clearance in healthy subjects
Scientific Title of Study	A randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of a novel herbal composition to relieve constipation and to improve bowel clearance in healthy subjects
Secondary IDs if Any	Secondary ID  Registry  CLS/GH/CL18100F4/19 Version No. 01 Dated 22-Nov-2019   Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Mr Kavangula Krishna Chaitanya   Address  CLS Pvt Ltd, Room No-201,First Floor, Pharmacology Department, Aswaraopet, Khammam TELANGANA 507301 India  Phone  8331015076   Fax     Email  highaspirer@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Mr Kavangula Krishna Chaitanya   Address  CLS Pvt Ltd, Room No-201,First Floor, Pharmacology Department, Aswaraopet, Khammam TELANGANA 507301 India  Phone  8331015076   Fax     Email  highaspirer@gmail.com
Details Contact Person Public Query Modification(s)	Name  Mr Ajjarapu Srinivasu   Address  CLS Pvt Ltd, Room No-101,Ground Floor, Sales Department, Aswaraopet, Khammam TELANGANA 507301 India  Phone  8331015016   Fax     Email  srinivasu.ajjarapu6567@gmail.com
Source of Monetary or Material Support	CLS Pvt Ltd, Aswaraopet,Khammam District, Telangana-507301
Primary Sponsor	Name  CLS Pvt Ltd   Address  Aswaraopet, Khammam District, Telangana-507301, India   Type of Sponsor  Other [Herbal exports]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Gogineni Naga Tejaswi  Aditya Multi Speciality Hospital   Door No.13-4-64, 4th Ln, 1 st Floor,Room No:102, General Medicine Division & Department,Gunturvarithota, Kothapeta, Pin-522001, India Guntur   8500454689 researchaditya26@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee- Aditya Multi Speciality Hospital for Dr Gogineni Naga Tejaswi  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Functional constipation
Intervention / Comparator Agent	Type  Name  Details  Intervention  CL18100F4-300mg   one capsule daily after dinner for 14 days  Intervention  CL18100F4-500mg  one capsule daily after dinner for 14 days  Comparator Agent  Placebo  one capsule daily after dinner for 14 days
Inclusion Criteria	Age From  25.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  •Male and female subjects aged between 25 and 60 years with BMI of 20 to 29 kg/m2. •Subjects meet the following Rome-III diagnostic criteria for Functional constipation: i.Must include two or more of the following: a.Straining during at least 25% of defecations b.Lumpy or hard stools in at least 25% of defecations c.Sensation of incomplete evacuation for at least 25% of defecations d.Sensation of anorectal obstruction/blockage for at least 25% of defecations e.Manual maneuvers to facilitate at least 25% of defecations (e.g. Digital evacuation, support of the pelvic floor) f.Fewer than three defecations per week ii.Loose stools are rarely present without the use of laxatives iii.There are insufficient criteria for irritable bowel syndrome. (NOTE: Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis) •Female subjects of childbearing potential must be using a medically acceptable form of birth control. Post-menopausal subjects must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. •Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent. •Subjects agree to be available for regular follow up throughout the study duration. •Subject considered generally healthy as per health history and routine clinical investigations during screening.
ExclusionCriteria	Details  •Subjects with secondary constipation (caused by medical condition or medication use). •Subject using drugs or supplements for gastrointestinal motility or laxatives. •Subject using dietary supplements like prebiotics or probiotics. •Subjects with history of medical conditions like cerebrovascular disease, depression, hypothyroidism, Irritable bowel syndrome or taking medicines like Antacids, Iron supplements, Opioids etc. •Subjects underwent treatment for COVID 19 or tested positive during the study will be excluded. •Women who are pregnant, lactating or planning to become pregnant during the study duration. •Subjects with any disease or abnormalities related to gastrointestinal tract, pancreas and liver. •Subjects with controlled hypertension and diabetes. •Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. •Subjects consuming alcohol or smokers. •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. •Expectation of any surgery during the study period. •Subject who participated in a clinical study within the last 30 days prior to recruitment or currently participating in another study. •Subjects with a known allergy or sensitivity to herbs/spices/plant products in general and/or allergic to botanical ingredients contained in the study product. •Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Pre-numbered or coded identical Containers
Blinding/Masking	Participant, Investigator and Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Change from baseline to end of the study period in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire  Day 1, Day 7 & Day 14
Secondary Outcome	Outcome  TimePoints  Change from baseline to end of the study period in Complete spontaneous bowel movement (CSBM)   Day 1, Day 7 & Day 14  Change from baseline to end of the study period in Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)   Day 1 & Day 14  Change from baseline to end of the study period in Physician/Patient global assessment (PGA)  Day 1, Day 7 & Day 14  Change from baseline to end of the study period in Questionnaire related to GI   Day 1, Day 7 & Day 14  Change from baseline to end of the study period in Serum Biomarkers   Day 1 & Day 14  Change from baseline to end of the study period in Use of rescue medication (Laxative)   Day 1, Day 7 & Day 14  Change from baseline to end of the study period in Victoria Bowel performance scale (BPS)   Day 1, Day 7 & Day 14  Change from baseline to end of the study period in Questionnaire related to stress and sleep   Day 1, Day 7 & Day 14  Change from baseline to end of the study period in Quality of life questionnaire (SF-36)  Day 1 & Day 14
Target Sample Size	Total Sample Size="48" Sample Size from India="48"
Phase of Trial	N/A
Date of First Enrollment (India)	24/11/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NIL
Brief Summary	The purpose of this study is to evaluate the efficacy of CL18100F4 to relieve constipation and to improve bowel clearance in healthy subjects. A total of 48 male and female subjects of age between 25 and 60 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either one of the three study groups (CL18100F4 300mg, CL18100F4 500mg or Placebo) at 1:1:1 ratio. The participants will be instructed to ingest one capsule containing the Investigational products daily for a period of 14 days. This study will measure Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL), Victoria Bowel performance scale (BPS), Questionnaire related to GI, Questionnaire related to stress and sleep, Quality of life questionnaire (SF-36), Physician/Patient global assessment (PGA), Use of rescue medication (Laxative), Complete spontaneous bowel movement (CSBM) and  Serum biomarkers of the participants as efficacy parameters. Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of the test product will also include the routine laboratory investigations on blood, urine and clinical chemistry parameters at screening and the final visit of the intervention.