| CTRI Number |
CTRI/2023/07/055837 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study on Amal Tablets in constipation |
|
Scientific Title of Study
|
A Clinical study to evaluate efficacy and safety of Amal Tablets in the Management of Functional Constipation and Irregular Bowel Habit-An Open Label, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMAL/AP/2023/1, Version 1.0, 17th April 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra Mundhe |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurvedic College and Hospital, Boradi |
| Address |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
09850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai.
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SANDOOK SUTRAS PVT. LTD.
Second Floor, Flat No.2 -A, Sukh Karta Apartments
Mhatre Bridge, Erandwane
Pune, Maharashtra - 411004
|
|
|
Primary Sponsor
|
| Name |
SANDOOK SUTRAS PVT LTD |
| Address |
Second Floor, Flat No.2 -A, Sukh Karta Apartments
Mhatre Bridge, Erandwane
Pune, Maharashtra - 411004
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendra Mundhe |
KVTR Ayurvedic College and Hospital Boradi |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist Dhule, 425428
Mobile no:- /7414986155
Email:-
Dhule
MAHARASHTRA |
09850378206
drnbmundhe@gmail.com |
| Dr Santosh Irayya Swami |
Seth Govindji Raoji Ayurved Mahavidyalaya attached Seth Sakharam Nemchand Jain Ayurved Hospital |
Department of Kayachikitsa, OPD No.02, Ground Floor, Seth Govindji Raoji Ayurved Mahavidyalaya attached Seth Sakharam Nemchand Jain Ayurved Hospital,118 -119, Shukrawar Peth, near old faujdar chawadi, Solapur 413001
Solapur
MAHARASHTRA |
9422957234
santosh.swami@sgrayurved.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KVPS, Karmavir V.T.Randhir Ayurved College, Boradi Tal-Shirpur, Dist-Dhule (425428) |
Approved |
| Institutional Ethics Committee, Seth Sakharam Nemchand Jain Aushadhalaya Trust’s Seth Govindji Raoji Ayurved Mahavidyalaya attached Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Marketed Preparation, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: 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 | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: AMAL TABLET, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: 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 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. 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)
|
|
| ExclusionCriteria |
| Details |
1. Subjects diagnosed with colonic inertia.
2. 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.
6. Subjects with uncontrolled DM and hypertension and Tuberculosis.
7. Known cases of HIV, tuberculosis, hypo and hyperthyroidism
8. Known cases of renal or liver dysfunction.
9. Subjects diagnosed with neurological problems like,
a). Parkinson’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.
11. 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
1. Change in stool form on ‘Bristol stool form scale’
2. Changes in symptoms of functional constipation including
3. Changes in associated clinical symptoms
4. Average time required for the subject to evacuate bowel after consumption of study medicine
5. Global assessment of overall change
6. Assessment of tolerability of study products
7. Assessment of laboratory investigations |
Screening visit (Up to 3 days), Baseline visit (Day 0), Visit 1 (Day 7), Visit 2 (Day 14), Visit 3 (Day 21) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
25/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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 ‘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 found
to significantly reduce Body Weight, BMI and other parameters related to
obesity and body fat. A significant increase was also observed in HDL levels.
All other laboratory parameters showed non-significant changes, providing
evidence of safety of CQ extract. Also, no Adverse event was observed with the
use of CQ extract. CQ extract can be recommended as a potential ingredient for
management of weight and obesity. A double blinded placebo controlled study is
recommended on a largest sample size for further validation. |