| CTRI Number |
CTRI/2024/08/071846 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Vaman Dhauti (Kunjal Kriya) and Guduchyadikwath in the management of Amalpitta W.S.R.Hyperacidity |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the effect of Vaman Dhauti (Kunjal Kriya) and Guduchyadikwath in the management of Amalpitta. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMANPREET KAUR |
| Designation |
Ayurvedic Medical Officer |
| Affiliation |
Government Ayurvedic Dispensary, Punjab Civil Secretariat-1 Chandigarh. |
| Address |
Government Ayurvedic Dispensary, Room no 1, Punjab Civil Secretariat-1 Chandigarh.
Chandigarh
CHANDIGARH
160001
India |
| Phone |
8146200068 |
| Fax |
|
| Email |
adv.kainth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neerja Sharma |
| Designation |
Professor in the Dept. of Swasthavritta |
| Affiliation |
Dhanwantri Ayurvedic College |
| Address |
neerja sharma, Department of Swasthavritta & Yoga, Dhanwantari Ayurvedic College,
CHANDIGARH
160047
India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
|
| Email |
neerjasharma2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neerja Sharma |
| Designation |
Professor in the Dept. of Swasthavritta |
| Affiliation |
Dhanwantri Ayurvedic College |
| Address |
Neerja Sharma,Department of Swasthavritta & Yoga, Dhanwantari Ayurvedic College,
CHANDIGARH
160047
India
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
|
| Email |
neerjasharma2966@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic Dispensary, Civil Secretariat,Chandigarh,Punjab |
|
|
Primary Sponsor
|
| Name |
Dr Amanpreet Kaur |
| Address |
Government Ayurvedic Dispensary, Punjab Civil Secretariat, Chandigarh
pin 160001 |
| 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 Amanpreet Kaur |
Governnment Ayurvedic Dispensary |
Governnment Ayurvedic Dispensary, Punjab Civil Secretariat, Chandigarh
Chandigarh
CHANDIGARH |
8146200068
adv.kainth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| district Ayurveda and Unani Officer, Mohali (Punjab) |
No Objection Certificate |
| GuruRavidasAyurvedicUniversityHoshiarpur |
Approved |
| GuruRavidasAyurvedicUniversityHoshiarpur |
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: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:kunjal kriya, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: guduchyadi kwath, Reference: chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients ready to give written consent.Patients presenting with classical features of Amlapitta.
Patients with chronicity of less than 3 years. |
|
| ExclusionCriteria |
| Details |
Patients not willing for the trial.Patients below age of 20 years and above 60 years of age.Patients using Aspirin or other NSAID’s Patients having any malignancy, history of gastric surgery, Cardiac problems, Tuberculosis, Diabetes Mellitus. Alarming symptoms like weight loss, GI bleeding and any other serious ailment.Patients having HIV, TB, or other grievous diseases.Any other patient considered unfit for inclusion criteria. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical features of amalpitta like HrithkanthaDaha ,Amlodgara ,Utklesha ,Avipaka ,Chhardi ,Aruchi,KukshiDaha,Udaradhmana |
0th day,1st week,2nd week, 3rd week, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Endoscopy will be done in case of Peptic ulcer. |
0th day, 28th day. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="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
Modification(s)
|
Amalpitta is the most common non-communicable disease of the digestive system affecting all age groups of both sexes. The clinical features HrithkanthaDaha (Restrosternal burning), Amlodgara (Sour and acidic eructation), Utklesha (Nausea),Avipaka (Indigestion), Chhardi (Vomiting), Aruchi (No desire to take food), KukshiDaha (Burning sensation in abdomen), Udaradhmana(Flatulence) etc. Ayurvedic classics and Yoga describes wide range of medicines and Shatkarma procedures in the treatment of Amalpitta. Acharya Chakradutta has given much emphasis on the role of Guduchyadi Kwath in Amalpitta. According to Hatha Yoga pradipika and Gheranda Samhita, Vaman Dhauti (Kunjal Kriya)helps in eradicating kapha-pitta rogas. So, a clinical study will be conducted on probable cases of Amalpitta for the periods of 30 days. Patients will be divided into two groups. Each group consists of 50 patients. Group A will be treated with Ayurvedic medicine Guduchyadi Kwath along with Vaman Dhauti (Kunjal Kriya). Group B will be treated with Ayurvedic medicine Guduchyadi Kwath. Observation on parameters will be done on 0th, 1st week, 2nd week, 3rd week, 4th week of the treatment. Analysis of the symptoms will be done statistically on the basis of results obtained in objectives and subjective parameters. Conclusion will be done on the basis of analysis of the data obtained. |