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CTRI Number  CTRI/2024/12/077553 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of drakshadi gutika in the management of amlapitta 
Scientific Title of Study   A randomised standard controlled clinical study to evaluate the effectiveness of Drakshadi Gutika in the management of 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  Dr Rupali Bandu Naik 
Designation  PG Scholar  
Affiliation  PDEAs college of ayurved and research centre nigdi pune  
Address  PDEAs college of ayurved and research centre Kayachikitsa department 3rd floor nigdi pune 411044 maharashtra India

Pune
MAHARASHTRA
411044
India 
Phone  9167074927  
Fax    
Email  rupali.naik0607@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rupali Tarachand Khobragade  
Designation  HOD 
Affiliation  PDEAs college of ayurved and research centre nigdi pune  
Address  PDEAs college of ayurved and research centre Kayachikitsa department 3rd floor nigdi pune 411044 maharashtra India

Pune
MAHARASHTRA
411044
India 
Phone  8378929859  
Fax    
Email  khobragaderupali19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rupali Bandu Naik 
Designation  PG scholar  
Affiliation  PDEAs college of ayurved and research centre nigdi pune  
Address  PDEAs college of ayurved and research centre Kayachikitsa department 3rd floor nigdi pune 411044 maharashtra India

Pune
MAHARASHTRA
411044
India 
Phone  9167074927  
Fax    
Email  rupali.naik0607@gmail.com  
 
Source of Monetary or Material Support  
PDEAs college of ayurved and research centre nigdi pune 411044 Maharashtra India  
 
Primary Sponsor  
Name  PDEAs college of ayurved and research centre nigdi pune  
Address  PDEAs college of ayurved and research centre Kayachikitsa department nigdi pune 411044 Maharashtra India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rupali Bandu Naik   Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi Pune  ayurved rugnalaya and sterling multispeciality hospital,nigdi pradhikaran,Sector no 27, kayachikitsa department, opd no 117, nigdi pradhikaran pune 411044 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9167074927

rupali.naik0607@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
College of ayurved and research centre akurdi pune 44 Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: AMLAPITTAM, (2) ICD-10 Condition:K21||Gastro-esophageal reflux disease. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Gudadi Modak , Reference: Yogratnakar amlapittanidanchikitsa adhyay gudadi Modak shlok no. 43, Route: Oral, Dosage Form: Modaka , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: - jal), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Drakshadi Gutika , Reference: Yogratnakar amlapittanidanchikitsa adhyay drakshadi gutika shlok no. 33-34, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are having at least 1 or more cardinal signs and symptoms of Amlapitta described in
Madhav nidan
Cardinal Symptoms –
Hrullas (Nausea),
Hrit-Kanthadaha (Heart burn),
Shirashul (Headache)
Tiktamla Udgara(acid eructation) 
 
ExclusionCriteria 
Details  1.The Known case of gastric ulcer, duodenal ulcer, stomach cancer, cancer of esophagus, esophageal varices, hematemesis.
2. Patients with long term use of painkiller & steroids.
3. Severe malnourished patient
4.pregnant and lactating women  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To compare the efficacy of Drakshadi Gutika 500 mg 1 tablet two times a day after meal with normal water and Guddi Modak 500 mg 1 tablet two times a day after meal with normal water in amlapitta for 21 days.
2. To give maximum symptomatic relief to patients after 21 days.
3. Relief from Tiktamla udhar, hritkanth daha, shirashul, hrullas. 		 21 days study with 3 followups on 7th, 14th and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
to study the adverse drug effects if any  21 days study with 3 followups on 7th, 14th and 21st day 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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   N/A 
Date of First Enrollment (India)   03/12/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The physiology of the gastrointestinal tract is disturbed in the
current period of rapidly changing lifestyles as a result of an
irregular meal schedule, lack of exercise, lack of sleep, poor eating
habits, and mental stress, which impairs Agni. Agni’s impairment
results in Agnimandya.
As described in Ayurveda,
रोगा: सर्वेअपि मन्देsग्नौ ।
अ.ह्र.नि.12/1
Agnimandya is the root cause of all the diseases. Agnimandya
causes indigestion of food.
This indigested food further leads to “Amlapitta”.
The word "amla" describes a certain flavour that is associated with
sourness and causes excessive salivary secretions. Pitta is a
biological chemical component that is mainly responsible for the
maintenance of the process of digestion and transformation.
Pitta dosha vitiation in the body is a pathological disease known as
amlapitta.
Pitta dosha possesses Katu rasa but when it becomes vitiated, it
transforms into Amla rasa.
After consumption of avirodhi, dushta bhojan, pittaprakopak aahar
pitta dosha present in our body exaggerated and becomes vidagdha
and causes symptoms like Hrullas (Nausea), TiktaAmlodgar (sour
and bitter blenching), Gaurava (feeling of heaviness in the body),
Hrit-Kantha daha (heart and throat burn), Aruchi (anorexia),
shirashul (Headache) evident clinically.
Ayurveda follows a holistic approach towards Amlapitta.
Ayurveda concentrate more on Agni Vriddhi and Aam Pachan by
various means. Having said this, there is a need for treatment which
can prevent complications of the disease, improve digestion,
relieves symptoms, cost-effective and easily available.
Drakshadi Gutika is mentioned in Yogratnakar for treatment of
Amlapitta. The ingredients present in this drug are Draksha, Haritaki,
Mishri.
These drugs shows an antagonistic action on the Prakupit Doshas
involved in Amlapitta. Therefore, this Kalpa is proposed to show an
efficient action on the pathology of the disease.Hence this drug is
used as a trial drug
In the previous study, Gudadi Modak was found to be significant in
the management of Amlapitta, therefore for the present study
Gudadi Modak will be taken as a control group.
 
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