| CTRI Number |
CTRI/2017/08/009285 [Registered on: 07/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Efficacy & Safety of Ayurvedic formulations "Active Antacid Suspension" and "Active Antacid Tablets" in management of acidity and indigestion |
|
Scientific Title of Study
|
A randomized controlled open label clinical study to evaluate the safety and efficacy of Active Antacid Suspension (DRF/AY/5018) and Active Antacid Tablets(DRF/AY/4026) in comparison with standard modern treatment in management of hyperacidity and functional dyspepsia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SD Pandey |
| Designation |
Professor Dept of Kayachikitsa |
| Affiliation |
Dhanwantary Hospital |
| Address |
Dhanwantary Hospital, Sector 40B
Chandigarh
CHANDIGARH
160047
India |
| Phone |
01723098869 |
| Fax |
01723098869 |
| Email |
soniadeepaktuli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head- Healthcare Research |
| Affiliation |
Dabur India Ltd. |
| Address |
Dabur India Ltd.
22, Site IV
Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
120337862314 |
| Fax |
1204552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head- Healthcare Research |
| Affiliation |
Dabur India Ltd. |
| Address |
Dabur India Ltd.
22, Site IV
Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
120337862314 |
| Fax |
1204552645 |
| Email |
arun.gupta@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited
22, Site IV, Sahibabad, Ghaziabad,
Uttar Pradesh
201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
22, Site IV, sahibabad, Ghaziabad-201010
Uttar Pradesh |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SD PANDEY |
Dhanwantary Ayurvedic College |
OPD Division
Department of Kayachikitsa,
Dhanwantary Ayurvedic College,
Sector 40B
Chandigarh
160047
India
Chandigarh
CHANDIGARH |
01723098869
soniadeepaktuli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dhanwantary Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active antacid suspension (DRF/AY/5018) |
Polyherbal antacid suspension comprising Glycyrrhiza glabra, Tinospora cordifolia, Eclipta alba, Operculina turpethum
Dose: 15 ml TDS and SOS |
| Intervention |
Active antacid tablet (DRF/AY/4026) |
Polyherbal antacid tablet comprising Glycyrrhiza glabra, Emblica officinalis, Asparagus racemosus, Operculina turpethum
Dose: 2 Tablets TDS after meals & SOS |
| Comparator Agent |
Marketed antacid suspension |
Magnesium Hydroxide & Aluminium Hydroxide with dimethicone
Dose: 15 ml TDS and SOS |
| Comparator Agent |
Marketed antacid tablets |
Aluminum Hydroxide / Magnesium Hydroxide / Simethicone
Dose: 2 Tablets TDS after meals and SOS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female subjects in the age group of 20 years to 50 years.
2. Subjects with greater than or equal to 24% of dyspepsia as per the Hong Kong Index of Dyspepsia
3. Subjects with absence of any clinical or ultrasonographic evidence of organic disease that was accounted for the symptoms
4. Subjects who were willing to sign informed consent and to come for regular followup
examinations as & when required.
5. In the event of subject undergoing treatment for dyspepsia, washout period of 2 days was given prior to inclusion. |
|
| ExclusionCriteria |
| Details |
1.Subjects with presence of or history of peptic and duodenal ulcers disease or gastric malignancy any gastrointestinal surgery, reflux oesophagitis, any upper or lower G.l. bleeding, with clinical evidence of irritable bowel syndrome or any psychiatric disease.
2. Subjects with clinically diagnosed serious medical or surgical illness (like: Diabetes,
CAD, HT, SLE, Rheumatoid Arthritis, Psoriatic Arthritis) where compliance was difficult.
3. Subjects not willing to follow up for the study visits.
4. Subjects with age range below 20 years and above 50 years
5. Uncooperative Subjects or subjects not willing to sign Informed Consent or giving
consent for study required procedure like endoscopy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Antacid Tablet (DRF/AY/4026 ) Antacid Suspension (DRF/AY/5018) in the Management of the Hyperacidity & Functional Dyspepsia in comparison to a marketed comparator.
|
day 7,14,21,28,35,42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate overall subject safety |
day 7,14,21,28,35,42 |
|
|
Target Sample Size
|
Total Sample Size="127"
Sample Size from India="127"
Final Enrollment numbers achieved (Total)= "127"
Final Enrollment numbers achieved (India)="127" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2007 |
| Date of Study Completion (India) |
01/08/2007 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results of this clinical study may be used for publishing scientific papers and data. All the data generated on the study will be exclusive property of sponsor; and no publication can be done without sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was a randomized open clinical study to evaluate the safety and efficacy of two Ayurvedic formulations - Active Antacid Tablets and Active Antacid Suspension in the management of the hyperacidity & functional dyspepsia in comparison to treatment with marketed antacid tablets and suspension. The study was conducted after obtaining prior IEC approvals from the IEC and written informed consent from all subjects before recruitment. A total of 127 male and female subjects aged between 20-50 years with functional dyspepsia and hyperacidity were recruited in the study as per the inclusion and exclusion criteria from Kayachikitsa OPD , Dhanwantary Ayurvedic College, Chandigarh and randomized as below: Group A (31 subjects) : Active Antacid Suspension : 15 ml TDS and SOS Group B (37) : Active Antacid Tablets : 2 Tablets TDS after meals and SOS Group C (26) : Active Antacid Suspension: 15 ml TDS and SOS Group D (33): Active Antacid Tablets: 2 Tablets TDS after meals and SOS The study period was of 6 weeks including 4 weeks of therapy and two follow-ups at weekly intervals after stoppage of treatment. Subjects were followed up at days 7,14,21,28 during the treatment period for the assessment of dyspepsia using The Hong Kong Index of Dyspepsia and at days 35 and 42 after withdrawal of study medication in order to study the lasting effect of treatments. |