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CTRI Number  CTRI/2024/05/067778 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study of Appelite Syrup for the treatment of Indigestion, Loss of Appetite, and Acidity. 
Scientific Title of Study   A prospective, open label, single centre study for evaluation of efficacy and safety of Appelite Syrup in the management of Dyspepsia (Indigestion),Loss of Appetite And Acidity 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HHCRS-HH&HPL-007/23-24 (Version-3.0 Dated-30/04/2024)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing Hands Clinic Pvt. Ltd. 
Address  Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashwin Porwal 
Designation  Principal Investigator 
Affiliation  Healing Hands Clinic Pvt. Ltd. 
Address  Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  9822347770  
Fax    
Email  drashwinporwal@healinghandsclinic.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Gajanan Bhagwat 
Designation  Manager Research & Development 
Affiliation  Research & Development Centre, Healing Hands & Herbs Pvt. Ltd. 
Address  101, Mangalmurti Complex, C.T.S. No. 990 Shukrawar Peth, Tilak Road, Pune- 411002. Maharashtra, India.

Pune
MAHARASHTRA
411002
India 
Phone  9404694494  
Fax    
Email  gajanan@healinghandsandherbs.org  
 
Source of Monetary or Material Support  
Healing Hands and Herbs Pvt. Ltd. 
 
Primary Sponsor  
Name  Healing Hands & Herbs Pvt. Ltd. 
Address  101, Mangalmurti Complex, C.T.S. No. 990 Shukrawar Peth, Tilak Road, Pune- 411002. Maharashtra, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Ashwin Porwal  Healing Hands Clinic Pvt. Ltd.  Ground Floor, Millenium Star Extension Adjacent to Ruby Hall Entrance Gate, Balkrishna Sakharam Dhole Patil Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA 		 9822347770

drashwinporwal@healinghandsclinic.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Healing Hands IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R630||Anorexia. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, (2) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Appelite Syrup , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: NA), Additional Information: NA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1.Patients aged above 18 years of age. 2.Patient with a diagnosis of Dyspepsia (indigestion) or loss of appetite or acidity. 3.Patient or Parent or legal guardian willing to give a written informed consent or parental consent or assent form. 4.Able to or Willing to strictly adhere to the investigator’s prescription. 
 
ExclusionCriteria 
Details  1.Individuals were excluded if they had taken any medications that might interfere with the action of the study medications prior to the start of the study or during the study.
2.Patients with a medical history and diagnosis of Diabetes were excluded from the study.
3.Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course
of study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Percentage of Participants with Overall Response.
2.Evaluate the changes in Dyspepsia (indigestion), Loss of appetite, and RDQ Score. 		 Up to 5 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of Participants with Treatment-Related Treatment-Emergent Adverse Events (TEAEs).
2.Safety evaluation of Appelite syrup.
3.Incidence of adverse events (AEs). 		 Up to 5 Weeks 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
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)   31/05/2024 
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="1"
Days="8" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response (Others) -  01/01/2025 TO 01/01/2030

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The Study is a Prospective, open-label, and single-centre study for evaluation of safety and efficacy of Appelite syrup in the management of Dyspepsia (indigestion), loss of appetite, and acidity. 
Eligible patients, both male and female above 18 years of age with symptomatic Dyspepsia (indigestion), loss of appetite, and acidity. The decision to prescribe Appelite Syrup will be made by the treating physician as per clinical judgement.
A detailed medical history will be obtained, and a physical examination will be conducted for each patient by the study investigators. The treatment duration is 04 weeks, and patients will be followed up till the end of the study (week 5).
At screening (Day -1 to Day 0), the potential patients will be identified by the site team, and written informed consent for patients aged 18 years and above will be procured before any study-related procedures are undertaken. The assessment, as per the schedule of assessments , would be performed at screening and enrolment to determine eligibility.
A total of 550 subjects will be enrolled in the study. The subject would be informed to visit the clinic in 01 weeks (Visit 2), 02 weeks (Visit 3), 04 weeks (Visit 4), and 05 weeks (visit 5). Safety assessment will be done throughout the duration of the study. 
 
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