| CTRI Number |
CTRI/2026/01/101572 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study To Evaluate the Efficacy Of Vaman Dhauti (Kunjal Kriya) In The Management Of patient with Urdhwaga Amlapitta With Special Refference To Hyperacidity |
|
Scientific Title of Study
|
A Clinical Study Of Efficacy Of Vaman Dhauti (Kunjal Kriya) On Urdhwaga Amlapitta 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 shubham Yashwant Maske |
| Designation |
PG scholar |
| Affiliation |
Bhausaheb Mulak Ayurved Mahavidyalaya And Research Hospital ,Nandanvan ,Nagpur |
| Address |
OPD,Dept. Of Swasthavritta and Yoga,Bhausaheb Mulak Ayurveda Mahavidyalaya and Research Hospital,Nandanvan,Nagpur
Nagpur MAHARASHTRA 440024 India |
| Phone |
7397801857 |
| Fax |
|
| Email |
shubham95maske@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhavi V Rehpade |
| Designation |
H.O.D. Dept. Of Swasthavritta And Yoga |
| Affiliation |
Bhausaheb Mulak Ayurved Mahavidyalaya And Research Hospital ,Nandanvan ,Nagpur |
| Address |
OPD,Dept. Of Swasthavritta and Yoga,Bhausaheb Mulak Ayurveda Mahavidyalaya and Research Hospital,Nandanvan,Nagpur
Nagpur MAHARASHTRA 440024 India |
| Phone |
9422146204 |
| Fax |
|
| Email |
madhavi309@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhavi V Rehpade |
| Designation |
H.O.D. Dept. Of Swasthavritta And Yoga |
| Affiliation |
Bhausaheb Mulak Ayurved Mahavidyalaya And Research Hospital ,Nandanvan ,Nagpur |
| Address |
OPD,Dept. Of Swasthavritta and Yoga,Bhausaheb Mulak Ayurveda Mahavidyalaya and Research Hospital,Nandanvan,Nagpur
Nagpur MAHARASHTRA 440024 India |
| Phone |
9422146204 |
| Fax |
|
| Email |
madhavi309@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| OPD of swashtyarakshan dept,Bhausaheb Mulak Ayuevedic medical college,nandanvan,Nagpur,Maharashtra,India,440024 |
|
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Primary Sponsor
|
| Name |
Bhausaheb Mulak Ayurved Mahavidyalaya And Research Hospital ,Nandanvan ,Nagpur |
| Address |
Bhausaheb Mulak Ayurved Mahavidyalaya And Research Hospital Nandanvan Nagpur |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubham Yashwant Maske |
Bhausaheb Mulak Ayurved Mahavidyalaya And Research Hospital |
OPD,Dept.Of Swasthavritta And Yoga Nagpur MAHARASHTRA |
9284632078
shubham95maske@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of Institute,BMAM,Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, (2) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: AMLAPITTAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Vaman Dhauti | (Procedure Reference: Gherand Samhita 1/38, Procedure details: Vaman Dhauti (kunjal kriya) Twice a Week)
|
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|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Group - 18 to 40 Years
2. Patient who have symptoms of Urdhwaga Amlapitta as mentioned in Ayurvedic texts like Avipaka, Utklesha,Chhardi,TiktaamlaUdgar,Aruchi,Hrud-Kanthdah, Gaurav ,Udarshool.
3.Irrespective of gender, caste , religion and socio-economic class.
4.Patients Co-operative for Trial. |
|
| ExclusionCriteria |
| Details |
1)Patient not willing to participate in the trial.
2)Patients below the age of 18 years and above 40 years.
3)Associated with any serious gastroenterological disease like Gastric ulcer
,Perforated ulcer,Duodenal ulcer,Cancer of any grade of oesophagus,Strictures of oesophagus,Abdominal Koch’s etc.(any surgical coindition),
4)Pregnant ladies and lactating mother.
5)Associated with any other serious systemic disease or complication like Diabetic melitus and insipidus, hypertension
6)Drug induced amlapitta. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Vaman Dhauti (Kunjal Kriya) on Urdhwaga Amlapitta symptoms like Avipaka,Utklesha,Chhardi,TiktaamlaUdgar,Aruchi,HrudKanthdah, Gaurav,Udarshool. |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the efficacy of Vaman Dhauti (Kunjal Kriya) on Urdhwaga Amlapitta.
2)To study Amlapitta disease as per Ayurvedic and Modern aspects.
3) To Study the Vaman Dhauti procedure. |
At 0th,7th,15th,21th,30th Day |
|
|
Target Sample Size
|
Total Sample Size="47" Sample Size from India="47"
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)
|
15/02/2026 |
| 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 |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
INTRODUCTION: Ayurveda is a unique boon to the community since ancient years. The science with a history of several thousand years has very strong principles on which it has developed. Ayurveda has mainly two principle objectives .First maintenance and promotion of health and Secondly pevention and cure from disease. Swasthavritta is the branch of ayurveda that deals with the pevention of any disease with the holistic approach by healthy lifestyle, diet,hygiene, daily regimen and yoga. The period of 21st century is regarded as the era of fast technology and tough competition. The man of this era is becoming prey to series of life style disorder which are much more bothering than the infective diseases. The altered life style activities like fried food, night shift duties, mental stress, addictions etc. are the major risk factors for the lifestyle disorders.Urdhwaa Amlapitta i.e .Hyperacidity is one of them. Urdhwaga Amlapitta, also known as Hyperacidity is generally a result of incorrect and irregular eating habits and it is one of the common ailments seen in many people.Hurry,Worry and Curry are the three main reasons for the amlapitta disease. In India reveals that 25% of the people are suffering from this disorder. Stomach contains acids that help in the process of digestion of food, When the level of these digestive acids increases, it starts to erosion of the mucus lining faster, and the stomach muscles become exposed leading to burning sensation and this condition is known as hyperacidity. According to Ayurveda, excess consumption of Pitta Prakopakara Ahara, Vihara leads to Amlata, Dravata, and Vriddhi of Pitta causing Shuktata of Pitta.The all above mentioned causes leads to imbalance of the Shareerika Doshas Vata, Pitta & Kapha in turn create Agnimandya & due to improperly metabolized and get convert into Shuktata (vitiated liquid acid) and this gets situated in Amashaya which is called as Amlapitta. The disease mainly caused by improper dietetic pattern, mental stress and strain which is related to our digestion. Vamana Dhauti one of the yogic Shatkarmas cleans the entire digestive tract and removes excess acid, bile, mucus, toxins and restores the natural balance of the stomach chemical composition. By considering the above factors Management of Amlapitta aims at minimizing the symptoms, correcting the Agni, Optimize the quality of life and reduces the risk of developing co-morbidities. Hence Ayurveda and Yogic procedures offers respectively as treatment modalities for resisting this types of disorders.This technique is also known as Gajkarni. RATIONAL OF STUDY : The digestive system plays an important role for the absorption of nutrients and the nourishment of overall body. the factors such as stress, lack of sleep, use of antibiotics, NSAIDs, improper water intake and poor dietary habits impaired digestive systems and cause the gastrointestinal disorders[GIDS] the severity of GID ’s varies as per disease types some like indigestion are mild while Acid peptic diseases such as hyperacidity, gastro esophageal Reflux disease [GERD], gastric and duodenal ulcer are life threatening conditions. It may cause malignant conditions like adenocarcinoma and other stomach cancer.About 7 lakh people died in 2002 due to stomach cancer. Amlapitta can be correlated with Acid Peptic Disorders which comprises of Hyperacidity,Gastro-Oesophageal Reflux Disease, Gastritis, Functional Dyspepsia described in modern science. In Gherand samhita and hathyog pradipika there is one wander ‘Vaman Dhauti suddhi kriya’ given and advised it’s Vaman Dhauti in amashaygat roga. Although there are treatments available in medical sciences for Amlapitta, no drug ensures relief. So there is need for safe, effective and easily perfrom Vaman Dhauti (Kunjal Kriya). Hence the study titled as "A Clinical Study Of Efficacy Of Vaman Dhauti (Kunjal Kriya) In The Management Of Amlapitta W.S.R. To Hyperacidity.” OBJECTIVES: Primary Objective- To study the efficacy of Vaman Dhauti (Kunjal Kriya) on Urdhwaga Amlapitta. Secondary Objectives- Ø To study the Amlapitta disease as per Ayurveda Literature . Ø To study the Hyperacidity as per Modern Literature. To study the Vaman Dhauti (Kunjal Kriya) procedure. ASSESMENT CRITERIA: Subjective parameters Based on sign & Symptoms of Urdhwag Amlapitta – Amlapitta Symptoms Rating Scale (ASRS) 1. Avipaka (Indigestion) 2. Utklesha (Nausea) 3. Chhardi (Vomiting) 4. Tiktaamla Udgar (Bitter & Sour Belching) 5. Aruchi (Anorexia) 6. Hrud-Kanthdah (Burning sensation in heart and throat) 7. Gaurav (Heaviness) 8. Udarshool (Stomachache)
Overall Effect of Therapy (Overall Assessment Criteria) :- Overall assessment will be done by following - 1. Not cured - No improvement in subjective Criteria 2. Improved - Improvement in Subjective criteria
3. Cured - Improvement in Subjective criteria
Excellent | 0 | 100% Relief in sign & symptoms | Very mild | 1-7 | 75-99% Relief in sign & symptoms | Mild | 8-14 | 50- 75% Relief in sign & symptoms | Moderate | 15-21 | 25-50% Relief in sign & symptoms | Severe (Infective) | 22-28 | 0-25% Relief in sign & symptoms. | Amlapitta Symptoms Rating Scale (ASRS)Minimum Score – 0 Maximum Score – 28 |