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CTRI Number  CTRI/2024/09/073407 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinial study to find the effect of two ayurvedic drugs drakshadi gutika and simhasyadi ghana vati in two groups of patients with functional dyspepsia  
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF SIMHASYADI GHANA VATI IN THE MANAGEMENT OF FUNCTIONAL DYSPEPSIA (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  Sindhana U 
Designation  P G Scholar Dept of Kayachikitsa SJSACH 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  7598497325  
Fax    
Email  sindhana25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vipin S G 
Designation  Associate Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8547626217  
Fax    
Email  drvipinsg@sjsach.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vipin S G 
Designation  Associate Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8547626217  
Fax    
Email  drvipinsg@sjsach.org.in  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet chennai-600123 
 
Primary Sponsor  
Name  Sindhana U 
Address  Department of Kayachikitsa Room noc17 Sri Jayendra Saraswathi Ayurveda college and Hospital Nazarathpet Poonamallee Chennai 600123 
Type of Sponsor  Other [Self] 
 
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 Sindhana U  Sri Jayendra Saraswathi Ayurveda College and Hospital  Dept of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai
Thiruvallur
TAMIL NADU 
7598497325

sindhana25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri jayendra saraswathi ayurveda college and hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Simhasyadi ghana vati, Reference: chakradatta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Drakshadi ghana vati, Reference: Ashtanga hridayam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient fullfilling the diagnostic criteria.
2.Participants from whom the written consent is obtained. 
 
ExclusionCriteria 
Details  1.K/C/O Peptic ulcer or any organic lesions and other systemic disorders.
2.Patients under NSAID s ,antibiotics or other long term and continuous medications.
3.History of Hematemesis.
4.Unintentional weight loss 5kg within 6months.
5.History of smoking and alcohol addiction.
6.Symptoms such as recurrent vomitting,bleeding through rectum,malena,anemia,dysphagia.palpable mass per abdomen.
7.Pregnant women and lactating mother. 
 
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 
Reduction of signs and symptoms of Functional dyspepsia   Reduction of signs and symptoms of Functional dyspepsia within 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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 
Date of First Enrollment (India)   16/09/2024 
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  

The classical reference of Amlapitta are from Kashyapa Samhita ,Yogaratnakara and Bhava-prakasha and Madhav Nidana,.In Amlapitta the root cause is Agnimandya and formation of Aama .Treatment of Amlapitta  : Agnideepaka and Aamapachaka drugs are used .Tikta Rasapradhana drugs are commonly Aamapachaka & Agnideepaka acts on annavaha srotas. All diseases are caused by Mandagni (weak digestive fire), which negatively affects the samana and udana vayu, as both vayu are responsible for proper digestion.The excessive consumption of Amla (sour), Katu (spicy), Ushna (hot), and Viruddhashana (incompatible food combinations) can lead to an aggravation of Pitta dosha. Normally, Pitta has a Katu rasa (spicy taste), but when it is converted into Amla rasa (sour taste), it results in Amlapittam. Diagnosis is done based on Rome IV criteria.

Trial drug : Simhasyadi ghana vati told in Chakradatta / Amlapitta adhikara.The ingredients are Vasa(Adatoda vasica ), Guduchi(Tinospora cardifolia ) and Brihati (Solanum indicum). It is indicated in Amlapitta,svasa,kasa and chardi expected to have effectiveness in Functional dyspepsia (Amlapitta). The mode of action of this yogam is Pittashamaka and Tridoshagna property due to its kashaya rasa , madura vipaka , laghu , snigha guna ,ushna veerya. It contains chemical constituents such as pyrroloquinazoline , glucosides which helps in healing the gastric mucosa.

 
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