A Clinical study on Amal Tablets in constipation

Phase 2/3

Completed

Conditions: Constipation. Ayurveda Condition: VIBANDHA,

Registration Number: CTRI/2023/07/055837

Lead Sponsor: SANDOOK SUTRAS PVT LTD

Brief Summary: It is a clinical study to evaluate efficacy and safety of Amal Tablets in the Management of Functional Constipation and Irregular Bowel Habit. The study will be conducted at 2 to 3 sites in India. Subjects will be randomized to one of the two study groups in 1:1 ratio. Subjects in the Amal Tablet group will be asked to take 2 tablets at bedtime with water for 14 days. Subjects in market preparation group will be asked to take 2 tablets at bedtime with water for 14 days. All the subjects will be asked to stop given medication after 14 days and will be followed for next seven days to observe recurrence of symptoms of functional constipation. The primary objective of the study will be to assess change in frequency of bowel movements. Secondary objectives of the study will be to assess change in stool form on â€˜Bristol stool form scale, changes in symptoms of functional constipation including, changes in associated clinical symptoms, average time required for the subject to evacuate bowel after consumption of study medicine, global assessment of overall change, tolerability of study products and laboratory investigations on screening visit (Up to 3 days), Baseline visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21)

Summary of Results:

CQ Extract was foundto significantly reduce Body Weight, BMI and other parameters related toobesity and body fat. A significant increase was also observed in HDL levels.All other laboratory parameters showed non-significant changes, providingevidence of safety of CQ extract. Also, no Adverse event was observed with theuse of CQ extract. CQ extract can be recommended as a potential ingredient formanagement of weight and obesity. A double blinded placebo controlled study isrecommended on a largest sample size for further validation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis a)Straining during more than one fourth (25 percentage) of defecations b)Lumpy or hard stools (Bristol Stool Form Scale 1to 2) more than one fourth (25 percentage) of defecations c)Sensation of incomplete evacuation more than one fourth (25 percentage) of defecations d)Sensation of anorectal obstruction/blockage more than one fourth (25 percentage) of defecations e)Manual manoeuvres to facilitate more than one fourth (25 percentage) of defecations (e.g., digital evacuation, support of the pelvic floor) f)Fewer than three SBM per week g) Loose stools are rarely present without the use of laxatives h)Insufficient criteria for irritable bowel syndrome 3.
Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
(The Rome 4 diagnostic criteria for Functional constipation, 2016).

Exclusion Criteria

Subjects diagnosed with colonic inertia.
Subjects who have recently undergone abdominal surgery 3.
Subjects with history of anorectal surgery.
4.Subjects having other functional gastrointestinal disorders other than Functional constipation (IBS, Belching disorders etc.) 5.
Subjects diagnosed with structural abnormalities, like: a).
Anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome b).
Perineal descent c).
Colonic or rectal mass or tumor with obstruction example adenocarcinoma d).
Colonic stricture: radiation, ischemia, diverticulosis e).
Intestinal obstruction.
Subjects with uncontrolled DM and hypertension and Tuberculosis.
Known cases of HIV, tuberculosis, hypo and hyperthyroidism 8.
Known cases of renal or liver dysfunction.
Subjects diagnosed with neurological problems like, a).
Parkinsonâ€™s disease b).
Multiple sclerosis c).
Sacral nerve damage (prior pelvic surgery, tumor) d).
Paraplegia e).
Autonomic neuropathy 10.
Subjects on chronic medication (greater than 60 days) and or who are on medications known to cause constipation.
Pregnant or lactating females 12.
Subjects allergic or atopic to any of the ingredients of the study medications 13.
Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in frequency of bowel movements	Screening visit (Up to 3 days), Baseline visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21)

Secondary Outcome Measures

Name	Time	Method
1. Change in stool form on â€˜Bristol stool form scaleâ€™	2. Changes in symptoms of functional constipation including

Trial Locations

Locations (2): KVTR Ayurvedic College and Hospital Boradi
🇮🇳
Dhule, MAHARASHTRA, India
Seth Govindji Raoji Ayurved Mahavidyalaya attached Seth Sakharam Nemchand Jain Ayurved Hospital
🇮🇳
Solapur, MAHARASHTRA, India
KVTR Ayurvedic College and Hospital Boradi
🇮🇳Dhule, MAHARASHTRA, India
Dr Narendra Mundhe
Principal investigator
09850378206
drnbmundhe@gmail.com