| CTRI Number |
CTRI/2025/03/082383 [Registered on: 17/03/2025] 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 evaluate the efficacy of
Pathyadi churna in the management of Vidagdhajirna w.s.r to
Hyperacidity. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of
Pathyadi churna in the management of Vidagdhajirna w.s.r to
Hyperacidity. |
| 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 Daisy Lal |
| Designation |
Postgraduate scholar |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Kayachikitsa Department Government Ayurvedic College and Hospital, Budhamurti, Kadamkuan, Patna , Bihar
Patna
BIHAR
800003
India |
| Phone |
9031993777 |
| Fax |
|
| Email |
daisy.lal.25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Professor and Head of Department Kayachikitsa |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Kayachikitsa Department Government Ayurvedic College and Hospital, Budhamurti, Kadamkuan, Patna , Bihar
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daisy Lal |
| Designation |
Postgraduate scholar |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Kayachikitsa Department Government Ayurvedic College and Hospital, Budhamurti, Kadamkuan, Patna , Bihar
Patna
BIHAR
800003
India |
| Phone |
9031993777 |
| Fax |
|
| Email |
daisy.lal.25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital |
| Address |
Government Ayurvedic College and Hospital, Budhamurti, Kadamkuan, Patna , Bihar 800003 India |
| Type of Sponsor |
Other [Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 India] |
|
|
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 Daisy Lal |
Government Ayurvedic College and Hospital |
Kayachikitsa Department OPD no 9 Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar
Patna
BIHAR |
9031993777
daisy.lal.25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K318||Other specified diseases of stomach and duodenum. Ayurveda Condition: VIDAGDHAJANYA-AJIRNAM/PITTAJA-AJIRNAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi churna, Reference: Bhaishajya Ratnavali - with Vidyotini Hindi Commentry by Kaviraj Shri Ambikadattasastri Ayurvedacharya, Chowkhamba Prakasan, Varanasi, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients between the age group of 16 -60 yrs
2 Patients diagnosed as Vidagdhajirna according to Ayurvedic classical features like will be
randomly selected irrespective of sex, religion and occupation. |
|
| ExclusionCriteria |
| Details |
1 Lactating and pregnant women
2 Patient suffering from other systemic illness which may interfere with course of treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from sign and symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of intervention w.r.t other |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
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="0"
Months="10"
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
|
Vidagdhajirna is a disorder of a Annavaha Srotas characterized by Trishna (excessive thirst), Moha (unconsciousness), Bhram (giddiness), Amloudgar (sour eructation), Daha (Burning sensation). Now in present era, due to bad food habits and improper life style with world. 80% of the top ten life threatening diseases of the world are due to faulty dietary habits. Vidagdhajirna is similar to hyperacidity. Due to various factors in the progressive civilization of the present day like speedy environmental changes, adaptation of newer & newer food materials, change in method of cooking, atmospheric pollution, encroachment of various chemical agents in newer life styles, occupational hazards etc. have precipitated the increasing trend of the diseases. Along with those stimulating factors tremendous stress, strain, disturbed sleep & anxiety have significantly aggravated the diseases including Vidagdhajirna. This is a life style problem and those who are addicted to tobacco, alcohol as well as excess of packaged food with rich salt content use of spices and non-vegetarian food can be easily caught by this disease. The prevalence of hyperacidity in India ranges from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies. |