| CTRI Number |
CTRI/2024/10/075853 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Hinstradi Kadha with Patoladi Kadha in Amlapitta [Acidity] |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study Efficacy Of Hinstradi Kwath With Patoladi Kwath In The Management Of Urdhwag Amlapitta |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Shejal Bhujangrao Inkar |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati |
| Address |
OPD No. 09, Kayachikitsa Department, Vidarbha Ayurved
Mahavidyalaya and G.N.T. Hospital, Dhanvantari Nagar, Amravati.
444605
India
Amravati
MAHARASHTRA
444605
India |
| Phone |
9503661768 |
| Fax |
|
| Email |
inkarshejal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vaishali H Wankhade |
| Designation |
Guide and HOD Departmaent of Kayachikitsa |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No. 09, Kayachikitsa Department, Vidarbha Ayurved
Mahavidyalaya, Dhanvantari Nagar, Amravati, Maharashtra.
New
Parijat Colony, Badnera Road, Amravati, Maharashtra. Vidarbha
Ayurved
Amravati
MAHARASHTR
Amravati
MAHARASHTRA
444605
India |
| Phone |
9420125432 |
| Fax |
|
| Email |
vaishalivhww@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Shejal Bhujangrao Inkar |
| Designation |
PG Scholar, Departmaent of Kayachikitsa |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No. 09, Department of Kayachikitsa, Vidarbha Ayurved
Mahavidyalaya, Dhanvantari Nagar, Amravati, Maharashtra.
PG Quater, Vidarbha Ayurved Mahavidyalaya, Dhanvantari Nagar,
Amravati, Maharashtra.
Amravati
MAHARASHTRA
Amravati
MAHARASHTRA
444605
India |
| Phone |
9503661768 |
| Fax |
|
| Email |
inkarshejal@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 09, Kayachikitsa Department, Vidarbha Ayurved Mahavidyalaya, Dhanvantari Nagar,Amravati |
|
|
Primary Sponsor
|
| Name |
Shejal Bhujangrao Inkar |
| Address |
Vidarbha Ayurved Mahavidyalaya, Dhanvantari Nagar, Amravati |
| 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 |
| Shejal Bhujangrao Inkar |
Vidarbha Ayurveda Mahavidyalaya, Amravati. |
OPD No.9, Kayahikitsa
Department, Vidarbha
Ayurveda
Mahavidyalaya and
Hospital, Dhanvantari
Nagar, Amravati.
Amravati
MAHARASHTRA
Amravati
MAHARASHTRA |
9503661768
inkarshejal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Vidarbha Ayurved Mahavidyala Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hinstradi Kwath , Reference: Nighanta Ratnakar Bhag 3/68: Amlapitta , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -25 ml bd with honey for 21 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patoladi Kwath , Reference: Yogratnakar , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -25 ml bd with honey for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with clinical signs and symptoms of Urdhwag Amlapitta will be selected.
2. Patients of age group between 20-50 years.
3. Patients will be selected irrespective of age, Sex, socio economic status. |
|
| ExclusionCriteria |
| Details |
1.Those patients who are not willing to give consent.
2. Patient will be excluded below age 20 years and above 50 years old.
3 Patient suffering from any infectious disease like bacterial or viral.
4. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done based on subjective criteria.
Subjective criteria is Avipak,Utklesha,Tikta Amla Udgara, Aruchi,Shirorujah,Gaurav
will be assessed based on before and after treatment. |
After 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="1" |
|
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
|
Topic:-"RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY EFFICACY OF HINSTRADI KWATH WITH PATOLADI KWATH IN THE MANAGEMENT OF URDHWAG AMLAPITTA"
Objectives Primary Objectives:-To evaluate the efficacy of Hinstradi Kwath in the management of Urdhwag Amlapitta. Secondary Objectives:-1.To compare the effect of Hinstradi Kwath and Patoladi Kwath in the management of Urdhwag Amlapitta.
Methodology :- Study design Screening of patients for inclusion Selection of patients on basis of Inclusion Criteria and Exclusion Criteria. Consent taken Grouping of Patients Trial will be conducted in our institute. Total 60 patients diagnosed with classical signs and symptoms of Urdhwag Amlapitta be selected and then will be divided in two groups. Hinstradi Kwath will be given to one group and Patoladi Kwath will be given to another one. The study will be conducted for 21 days. Result will be compared in two groups. Data analysis will be done by using appropriate statistical test.
INCLUSION CRITERIA 1.Patients with clinical signs and symptoms of Urdhwag Amlapitta will be selected. 2. Patients of age group between 20-50 years. 3. Patients will be selected irrespective of age, Sex, socio economic status.
Exclusion Criteria:- 1.Those patients who are not willing to give consent. 2. Patient will be excluded below age 20 years and above 50 years old. 3Patient suffering from any infectious disease like bacterial or viral. 4.Pregnant and lactating women.
Withdrawal Criteria :- 1. Patients who refuse to treatment. 2. Patients with irregular follow up. 3.If any complication or adverse effect found during period of treatment. 4.If symptoms aggravated during treatment will be withdrawn.
|