| CTRI Number |
CTRI/2025/03/081782 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Drakshadi Ghrita in the management of Pittaj Gulma |
|
Scientific Title of Study
|
Evaluation of the efficacy of Drakshadi Ghrita in Pittaj Gulma - A 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 Hrushikesh Dattatraya Gore |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr. D Y Patil college of Ayurveda and Research centre , Pimpri, Pune |
| Address |
OPD no. 5 of Dr. D Y Patil college of Ayurveda and Research centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
08605102371 |
| Fax |
|
| Email |
gorehrushikesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D. G. Dipankar |
| Designation |
MD Kayachikitsa |
| Affiliation |
Dr. D Y Patil college of Ayurveda and Research centre , Pimpri, Pune |
| Address |
OPD no. 5 of Dr. D Y Patil college of Ayurveda and Research centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
digambar.dipankar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hrushikesh Dattatraya Gore |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr. D Y Patil college of Ayurveda and Research centre , Pimpri, Pune |
| Address |
OPD no. 5 of Dr. D Y Patil college of Ayurveda and Research centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
08605102371 |
| Fax |
|
| Email |
gorehrushikesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D Y Patil college of Dr Ayurveda and Research centre, Pimpri, Pune, 411018, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Hrushikesh Dattatraya Gore |
| Address |
OPD no. 5 of Dr. D Y Patil college of Ayurveda and Research centre, Pimpri, Pune, 411018, Maharashtra, India |
| Type of Sponsor |
Other [(self)] |
|
|
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 Hrushikesh Dattatraya Gore |
Dr D Y Patil College of Ayurveda and Research Center, Pimpri, Pune |
OPD no 5, Kayachikitsa department
Pune
MAHARASHTRA |
8605102371
gorehrushikesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation. Ayurveda Condition: PITTAJAGULMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi Ghrita, Reference: Charak Samhita, Chikitsa Sthan, Chapter no 5, Shloka no. 123, 124, 125, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -sugar candy and honey in one fourth quantity of ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms of Pittaj Gulma such as excessive thirst, abdominal pain, excruciation pain during digestion of food, sweating and burning sensation, tenderness in abdomen, sour belching. |
|
| ExclusionCriteria |
| Details |
Patients suffering from Ulcerative colitis,Crohn’s disease, uncontrolled Diabetes Mellitus, Cancer, AIDS, Tuberculosis and known pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The symptoms of Pittaj Gulma will reduce. |
15 days with follow up on 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain will be reduced on basis of VAS Scale. |
15 days with follow up on 7th and 15th day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2025 |
| 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="1"
Months="6"
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
|
The aim of the study is to see the efficacy of Drakshadi Ghrita in the management of pittaj gulma .
The study will be conducted on 30 patients having symptoms of pittaj gulma .
10 ml Drakshadi ghrita should be given twice a day empty stomach for the duration of 15 days and follow up on 7th and 15th day.
Final conclusion will be drawn on the basis of statastical methods . |