| CTRI Number |
CTRI/2025/01/078843 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dronapuspi (Leucas cephalotes) for peptic ulcer disease healing. |
|
Scientific Title of Study
|
Exploring the ulcer healing potential of Dronapuspi (Leucas cephalotes) in parinamshoola (peptic ulcer disease) : A preclinical and clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Kumar Taraphder |
| Designation |
Professor, Dept. of Dravyaguna Vijnana, IPGAE&R at SVSP. |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
Dept. of Dravyaguna Vijnana, Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. 294/3/1, A.P.C. Road ,Kolkata.
West Bengal-700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Taraphder |
| Designation |
Professor, Dept. of Dravyaguna Vijnana, IPGAE&R at SVSP. |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
Dept. of Dravyaguna Vijnana, Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. 294/3/1, A.P.C. Road ,Kolkata.
West Bengal-700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trisha Mukhopadhyay |
| Designation |
M.D. Scholar Dept. of Dravyaguna Vijnana IPGAE&R at S.V.S.P.. |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
Dept. of Dravyaguna Vijnana, Room No. T2, Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. 294/3/1, A.P.C. Road ,Kolkata.
West Bengal-700009.
Kolkata
WEST BENGAL
700009
India |
| Phone |
7439792282 |
| Fax |
|
| Email |
tutimukherjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, Govt. of West Bengal. 294/3/1 A.P.C. Road Kolkata 700009. |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
| Address |
294/3/1 A.P.C. Road, Kolkata- 700009 |
| Type of Sponsor |
Government medical college |
|
|
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 AMIT TARAPHDAR |
Institute Of Post Graduate Ayurvedic Education and Research at S.V.S.P. Hospital |
Room No. T2, Dept. of Dravyaguna 294/3/1, A.P.C. Road, Kolkata, 700009. Kolkata, West Bengal
Kolkata
WEST BENGAL |
9874849650
atipgaer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL CLINICAL ETHICAL COMMITTEE , I.P.G.A.E.&R., KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K277||Chronic peptic ulcer, site unspecified, without hemorrhage or perforation. Ayurveda Condition: PARINAMASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DRONAPUSPI, Reference: SAHASRA YOGA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | SUCRALFATE | SUCRAL FATE IN SUSPENSION FORM - 10ML TWICE A DAY AFTER MEAL AT NOON AND AT NIGHT FOR 30 DAYS. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from-
i) Feeling very full or bloated after a meal.
ii) Persistant heartburn.
iii) Feeling nausea
iv) Vomiting. |
|
| ExclusionCriteria |
| Details |
i) Bleeding inside intestines.
ii) Perforation of intestinal wall.
iii) Haematemesis.
iv) Pregnant women.
v) Lactating mother.
vi)Malignancy
vii) age greater than 60 years and lesser than 20 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the ulcer healing property of dronapuspi by monitoring the symptoms and signs of patients suffering from peptic ulcer disease. |
30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of test drug on quality of life among the patients suffering from peptic ulcer disease. |
30 days. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This clinical study, which will take place at OPD of the IPGAE&R at SVSP Hospital, is a randomized, parallel-grouped control trial of a test drug comparing the efficacy of Sucral fate for 30 days in 20 patients with peptic ulcer disease. The primary outcome of this research is to evaluate the therapeutic efficacy of the test drug for its potential ulcer healing property in managing peptic ulcer disease. The secondary outcome is to determine the safety of the Test drug on quality of life among the patients suffering from peptic ulcer disease. |