Clinical trials to evaluate the efficacy of Dashang Agad in Dengue Fever.

Phase 2/3

Not yet recruiting

• Conditions: Dengue fever [classical dengue]. Ayurveda Condition: Keeta,

• Registration Number: CTRI/2025/03/083451
• Lead Sponsor: Government Ayurvedic College and Hospital Dharashiv

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-25
• Study Start: 2025-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Dashang agad in Dengue fever	On 1st,3rd,7th,15th day of trial.

Secondary Outcome Measures

Name	Time	Method
1.To study Ayurvedic and modern literature regarding Dengue fever.	2.To minimize the side effects of modern medicine

Trial Locations

Locations (1)

Government Ayurvedic College and Hospital Dharashiv; 🇮🇳 Osmanabad, MAHARASHTRA, India

Government Ayurvedic College and Hospital Dharashiv

🇮🇳Osmanabad, MAHARASHTRA, India

Dr Rajeshree Nagnath Gadekar

Principal investigator

9309958637

rajeshreegadekar11@gmail.com