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CTRI Number  CTRI/2025/03/083451 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trials to evaluate the efficacy of Dashang Agad in Dengue Fever. 
Scientific Title of Study   Randomised controlled clinical trials to evaluate the efficacy of Dashang Agad in the management of Dengue Fever w.s.r.to Thrombocytopenia and Leucopenia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajeshree Nagnath Gadekar 
Designation  PG Scholar  
Affiliation  Government Ayurvedic College and Hospital Dharashiv  
Address  Agadtantra Department Opd no 12 Ground Floor Government Ayurvedic College and Hospital Tuljapur Road Dharashiv

Osmanabad
MAHARASHTRA
413501
India 
Phone  9309958637  
Fax    
Email  rajeshreegadekar11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N S Gangasagre 
Designation  Professor and HOD Agadtantra Department  
Affiliation  Government Ayurvedic College and Hospital Dharashiv  
Address  Agadtantra Department Opd no 12 Ground Floor Government Ayurvedic College and Hospital Tuljapur Road Dharashiv

Osmanabad
MAHARASHTRA
413501
India 
Phone  9422165970  
Fax    
Email  gacosbd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N S Gangasagre 
Designation  Professor and HOD Agadtantra Department  
Affiliation  Government Ayurvedic College and Hospital Dharashiv  
Address  Agadtantra Department Opd no 12 Ground Floor Government Ayurvedic College and Hospital Tuljapur Road Dharashiv

Osmanabad
MAHARASHTRA
413501
India 
Phone  9422165970  
Fax    
Email  gacosbd@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital Tuljapur Road Dharashiv 413501 
 
Primary Sponsor  
Name  Government Ayurvedic College and Hospital Dharashiv  
Address  Government Ayurvedic College and Hospital Tuljapur Road Dharashiv Maharashtra India 413501 
Type of Sponsor  Other [Government Ayurvedic College and Hospital Dharashiv ] 
 
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 Rajeshree Nagnath Gadekar   Government Ayurvedic College and Hospital Dharashiv  Agadtantra Department Opd no 12 Government Ayurvedic College and Hospital Tuljapur Road Dharashiv
Osmanabad
MAHARASHTRA 		 9309958637

rajeshreegadekar11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurvedic college Dharashiv Maharashtra India 413501  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:A90||Dengue fever [classical dengue]. Ayurveda Condition: Keeta,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dashang Agad , Reference: Ashtang Hruday Uttartantra , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: Dashang Agad given with paracetamol, oral hydration therapy, antiemetic,IV fluids, antibiotics as per required.
2Comparator Arm (Non Ayurveda)-Paracetamol, oral hydration therapy, antiemetic, IV fluids, antibiotics as per required.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient of age from 18yrs to 60 yrs
2.Patient Who gives written informed consent
3.Patient of either sex
4.Diagnosed cases of Dengue fever
5.Patient irrespective of cast religion economic status
 
 
ExclusionCriteria 
Details  1.Patients of HIV HBsAg positive
2.Patients of Dengue with uncontrolled DM HTN Kochs any systemic diseases
3.Patients of DHF and DSS
4.Patients having platelet count below 50,000
5.patients not willing for trial
6.pregnant females and lactating mothers.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Dashang agad in Dengue fever   On 1st,3rd,7th,15th day of trial. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study Ayurvedic and modern literature regarding Dengue fever.
2.To minimize the side effects of modern medicine
3.To minimize the complications of Dengue fever  		 On 1st,3rd,7th,15th day of trial. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   05/04/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [rajeshreegadekar11@gmail.com].

  6. For how long will this data be available start date provided 31-10-2025 and end date provided 15-03-2030?
    Response (Others) -  Date mention

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Thank you
Brief Summary  
After clearance of institutional ethics committee of Government Ayurvedic college Dharashiv screening of population will be done from patient in OPD, IPD of our institute , Civil Hospital and periphery. In clinical study of 60 patients of Dengue fever will include. If patients fulfill the criteria of inclusion, subject would also given freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in the study.

The treatment will be given to patient as follows:

Group A (Trial Group) : Dashang Agad - 3gm TDS (15 Days) with Paracetamol,Oral Hydration Therapy,antiemetic,IV Fluid, antibiotics as per required.

Group B (Control Group) : Paracetamol,Oral Hydration Therapy,antiemetic,IV Fluid, antibiotics as per required.

In study Assessment of Grading scale of symptoms and CBC will be assessed as per need on 1st day, 3rd day,7th day and final assessment of patient will be done on 15th day.

Medium of Dissertation: The study will be written in English and Sanskrit words will be used wherever necessary.

Study Design: Randomized Controlled Clinical Trial.

Duration of Treatment: 15 days

Ethical Clearance: Clearance from Institutional Ethics Committee will be taken.

Study Centre: OPD, IPD of Mother institute, Civil Hospital and periphery.

Duration of study: Study will be carried out for 18 months.

Study Population:
1. All the patients of Dengue fever attending OPD, IPD of our institute , civil Hospital and periphery of our institute will be considered in this study.
2. Patients in between 18 to 60 years of age.
3. Patients will be diagnosed on the basis of symptoms and laboratory investigations.

Sample Size:
Sample size calculated by Daniel’s formula.
Prevalence rate of Dengue fever is 38.3 out of 100.

Daniel’s formula-

Sample size (n)= Z2 p(1-p)/e2

Where n = Sample Size

z= Level of Signification (1.96)

p = Prevalence Rate (0.383)

e = Standard Error (5%)

n = (1.96)2 x 0.383(1-0.383) ÷ (0.5) 2 
 n=2

But there is no statistical analysis on the basis of 2 sample size so 60 will be taken as sample size and divided into two groups.

Assessment will be done on the basis of following criteria’s:

A) Subjective Criteria:
1.Gradation of Vomiting 
2.Gradation of Abdominal pain 
3.Gradation of Arthralgia 
4.Gradation of Petechiae/Rash


B) Objective Criteria:
1.Gradation of Fever (Temperature using Thermometer)
2.Gradation of Thrombocytopenia (from CBC Report)
3.Gradation of Leucopenia(from CBC Report)
4.Tourniquet Test.

C) Overall Assessment Criteria - Overall assessment will be done on the basis of Marked Improvement, Moderate Improvement, Mild Improvement, No Improvement.

Finally, Observation, Discussion, Conclusion will be done.






 
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