| CTRI Number |
CTRI/2025/10/095893 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Pharmaco clinical study of effect of Drakshadi Gutika and Pathyadi Churna in HyperAcidity |
|
Scientific Title of Study
|
A Pharmaco clinical study to evaluate the effectiveness of Drakshadi Gutika and Pathyadi Churna in Urdhwag Amlapitta WSR to GERD |
| Trial Acronym |
.nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeetika Yadav |
| Designation |
MD Scholar |
| Affiliation |
State ayurvedic college and hospital, Lucknow |
| Address |
P.G. Dept. of Dravyaguna state ayurvedic college and hospital, Lucknow 226003 uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9431067276 |
| Fax |
|
| Email |
jeetika.yadav7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Makhan Lal |
| Designation |
Professor |
| Affiliation |
State ayurvedic college and hospital, Lucknow |
| Address |
P.G. Dept. of Dravyaguna state ayurvedic college and hospital, Lucknow 226003 uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9454363904 |
| Fax |
|
| Email |
makhanlal810@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Makhan Lal |
| Designation |
Professor |
| Affiliation |
State ayurvedic college and hospital, Lucknow |
| Address |
P.G. Dept. of Dravyaguna state ayurvedic college and hospital, Lucknow 226003 uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9454363904 |
| Fax |
|
| Email |
makhanlal810@gmail.com |
|
|
Source of Monetary or Material Support
|
| State ayurvedic college and hospital, Lucknow, Uttar Pradesh 226003, India |
|
|
Primary Sponsor
|
| Name |
State ayurvedic college and hospital, Lucknow |
| Address |
State ayurvedic college and hospital, Lucknow 226003 Uttar Pradesh, India |
| 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 Jeetika Yadav |
State ayurvedic college and hospital, Lucknow |
P.G. Dept. of Dravyaguna ,State ayurvedic college and hospital, Lucknow 226003, Uttar Pradesh , India
Lucknow
UTTAR PRADESH |
9431067276
jeetika.yadav7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of institutional ethics committee , state ayurvedic college and hospital , lucknow tulsidas marg, turiyaganj , pin code 226003, uttar pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Churna, Reference: Chakradatt, Amlapitta Chikitsa Adhyay 52, Shlok number 13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi Gutika, Reference: Yog Ratnakar Chikitsa uttardh, Amlapitta chikitsa adhyay, Drakshadi Gutika, Shlok number 1,2, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. socio economic status : all
2. The patients with classical signs and symptoms of Amlapitta given in various texts as well as the clinical features of disease of GERD given in Modern medicine
3. Those patients who are willing to give written consent to participate in the study will be included. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of systemic illness like cardiac disease & Diabetes mellitus.
2. Patients with history of gastric ulcer, duodenal ulcer, achalasia, hiatal hernia.
3. Pregnant ladies and lactating mothers.
4. Patient with drug induced Amlapitta. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. sour eructation
2. retrosternal burning
3. indigestion
4. tiredness without excertion
5. nausea
6. heaviness of body
7. anorexia |
the follow up conducted during study period for once in 15 days. After completion of trial of two month, the follow up without drug after 15 days for one month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.CBC
2.BLOOD SUGAR(FBS,PPBS)
3.LFT, KFT, LIPID PROFILE
4. CHEST XRAY, USG ABDOMEN, H. PYLORI, STOOL EXAMINATION FOR OVA,CYST,OCCULT BLOOD (IF NECESSARY)
|
the follow up conducted during study period for once in 15 days. After completion of trial of two month, the follow up without drug after 15 days for one month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
27/10/2025 |
| 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="0"
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
|
An Amlapitta patients experinces difficult in persuing day to day activity. therefoe , i select this trail. This research evaluate the effectivness of Drakshadi Gutika and Pathyadi Churna. this research is parallel group randomised clinical study of 60 patients. Group A (n=30), the patient will be given Drakshadi gutika 6gm twice a day with luke warm water after meal. Group B (n=30), the patientrs will given Pathyadi Churna 3gm twice a day with lukewarm water after meal. duration of trial = 2 months follow up conducted during study periods for once in 15 days after completion of trial of 2 months , the follow up without drugs after 15 days for one month. |