| CTRI Number |
CTRI/2024/08/073137 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Vamanam (Madanphal Patola Arishtaadi)
And Experimental Group In The Management Of Urdhwag Amlapitta (Hyperacidity) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Vamanam (Madanphal Patola Arishtaadi) And Experimental Group In The Management Of Urdhwag Amlapitta (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 Sadhana Dadhich |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Campus Karwad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005861047 |
| Fax |
|
| Email |
drsanu24091995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Campus Karwad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Dadhich |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institue of Ayurveda |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Campus Karwad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8005861047 |
| Fax |
|
| Email |
drsanu24091995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur 342037 Rajasthan INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sadhana Dadhich |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
Room no 11 PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur
Jodhpur
RAJASTHAN |
8005861047
drsanu24091995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurveda Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K297||Gastritis, unspecified. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (Procedure Reference: Bhav Prakash, Procedure details: Procedure details: Procedure details: The procedures will be performed in three different steps:- 1.Poorva Karma 2.Pradhana Karma 3.Paschat Karma Both the procedures will be performed according to the method mentioned in classical text. About Vamana Therapy It is one of the Panchakarma treatment of Ayurveda, which means induced emesis for therapeutic purpose. ))
(1) Medicine Name: Madanphal Madhu Sandhav and Patola Arishta Phant and control group , Reference: Bhav Prakash, Route: Oral, Dosage Form: Phanta, Dose: 2000(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (Procedure Reference: Bhav Prakash, Procedure details: Procedure details: The procedures will be performed in three different steps:- 1.Poorva Karma 2.Pradhana Karma 3.Paschat Karma Both the procedures will be performed according to the method mentioned in classical text. About Vamana Therapy It is one of the Panchakarma treatment of Ayurveda, which means induced emesis for therapeutic purpose. )
(1) Medicine Name: Madanphal Madhu Sandhav and Patola Arishta Phant, Reference: Bhav Prakash, Route: Oral, Dosage Form: Phanta, Dose: 2000(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and confirmed cases of Urdhwaga Amalpitta (Hyperacidity) as per Case Report Form & on the basis of the sign & symptoms.
Patients between the age group of 16-60 years of either sex, religion, occupation.
Patients who willing to give written consent form.
Patients who are yogya for vamanam. (Charak sidhi 2).
|
|
| ExclusionCriteria |
| Details |
Patient with age below 16 year and above 60 year.
Patient with severe IBS.
Known case of peptic & gastric ulcer.
Hematemesis (blood vomiting),nasal bleeding, hemophilia etc.
Tumor of the abdomen.
Patient who are ayogya for vamanam. (Charak sidhi 2) like
Kshata (Chest Injury)
Kshina (Emaciated)
Atisthula (Excessively Obese)
Atikrisha (Excessively Lean)
Baala (Children)
Vriddha ( Old)
Durbala (Weak)
Shraanta (Fatigued)
Pipasita (Thirsty)
Kshudhita (Hungry)
Karmahata (Work Related Fatigue)
Bhaarahata (Exhaustion due to carrying heavy weight)
Adhvahata (Exhaustion due to wayfaring)
Upavaasa-prasakta-kshaama (Weakness due to excessive Fasting)
Maithuna- prasakta-kshaama(Exhaustion due to excessive Sexual activities)
Adhyayana- prasakta-kshaama(Exhaustion due to excessive Acedemic activities)
Vyayama- prasakta-kshaama(Exhaustion due to excessive Physical exercise)
Chinta- prasakta-kshaama(Exhaustion due to excessive worry)
Garbhini (Pregnant woman)
Sukumara (One having tender health)
Samvritta Koshtha (One having Obstructed bowel)
Dushchardana (One who does not respond to emesis easily)
Urdhvaraktapitta(One who suffering from bleeding from the upper tract)
Prasaktachhardi( One who suffering from continuous Vomiting)
Urdhvavata(One who suffering from Upward movement of vata)
Asthapita (One who has taken Medicated enema having higher amount of decoction)
Anuvasita (One who has taken Medicated enema having higher amount of snehan)
Hridroga (Heart disease)
Udavarta (Disorder due to improper functioning of vata)
Mutraghata(Anuria/oliguria)
Pleeha- Roga (Splenic disorder)
Gulma(Abdominal lump)
Udara- roga (Obstinate abdominal diseases including Ascites)
Ashtheela (Enlarged Prostate)
Swaropaghaata (Choked voice)
Timira (Cataract)
Shirahshoolaarta(One who suffering from headache)
Shankhashoolaarta (One who suffering from temporal pain)
Karnashoolaarta(One who suffering from ear pain)
Akshishoolaarta(One who suffering from pain in eyes)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect on subjective and objective parameters |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see any other effects of drug & procedure |
16 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 interventional study will be done on number of
patients of 30 with two group 15 patients with administration of vamanam with
experimental group in group A and 15 patients with administration of vamanam
without experimental group in group B for 6 months . The patients will be
assessed on basis of subjective criteria of Urdhwag Amlapitta before and after
trial .Follow up will be taken on every 15th day. The data will be collected and
analyzed statistically using appropriate test.
|