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CTRI Number  CTRI/2024/10/075249 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Safety & Efficacy of Zandu Ayurvedic Cough syrup in Dry & Productive cough 
Scientific Title of Study   Evaluation of the safety & efficacy of Zandu Ayurvedic Cough Syrup in the management of symptoms associated with Vataja, Pittaja & Kaphaja Kasa (Dry & Productive Cough) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Radha Ballabha Sati 
Designation  Professor & Campus Director 
Affiliation  Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11 
Address  Department of Rog Nidan, OPD no.11, Hospital Block, Uttarakhand Ayurved University, Main campus, Station Road, Harrawala

Dehradun
UTTARANCHAL
248001
India 
Phone  8077747461  
Fax    
Email  dr.ashka@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Radha Ballabha Sati 
Designation  Professor & Campus Director 
Affiliation  Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11 
Address  Department of Rog Nidan, OPD no.11, Hospital Block, Uttarakhand Ayurved University, Main campus, Station Road, Harrawala

Dehradun
UTTARANCHAL
248001
India 
Phone  8077747461  
Fax    
Email  dr.ashka@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prof Radha Ballabha Sati 
Designation  Professor & Campus Director 
Affiliation  Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11 
Address  Department of Rog Nidan, OPD no.11, Hospital Block, Uttarakhand Ayurved University, Main campus, Station Road, Harrawala

Dehradun
UTTARANCHAL
248001
India 
Phone  8077747461  
Fax    
Email  dr.ashka@yahoo.com  
 
Source of Monetary or Material Support  
Zandu Emami Ltd Emami Limited 8, Bentick Street, 10th Floor, Taher Mansion, Kolkata 700001, India 
 
Primary Sponsor  
Name  Zandu Emami Ltd 
Address  Emami Limited 8, Bentick Street, 10th Floor, Taher Mansion, Kolkata 700001, 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 
Prof R B Sati  Uttarakhand Ayurved University- Main Campus Hospital, Faculty of Ayurveda, Dehradun  Room no. 01, Department of Kayachikitsa OPD & Room no.11, Department of Rog Nidan OPD, Hospital Block, Main Campus Uttarakhand Ayurved University Station Road, Harrawala, Dehradun
Dehradun
UTTARANCHAL 		 8077747461

dr.ashka@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Main Campus, Faculty of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Zandu Ayurvedic Cough Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering from below mentioned minimum with three symptoms:
1. Persistent cough
2. Hoarseness of voice
3. Sore throat / Throat irritation /itching/ burning
4. Difficulty in expectorating phlegm / Expectorate viscous phlegm while coughing
5. Cold/running nose
 
 
ExclusionCriteria 
Details  1. Cough associated with other respiratory disorders like Bronchial carcinoma, Bronchial Asthma, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung-disease, tropical pulmonary eosinophilia

2. Diabetes Mellitus, Hypertension and other serious cardiovascular disorders.
3. Any other serious illness e.g. Hepatic/ renal failure/severe anaemia
4. Known hypersensitivity or allergy to one or more of the herbal ingredients
5. participation in a clinical trialin last 1 month
6. use of any Herbal/Ayurvedic drugs in last 1 month
7. Other debilitating neurological or psychiatric disorders
8. Any condition likely to hinder compliance with the protocol.
9. Severe infective / other organic illness.
10. Any concomitant serious disorder of organs.
11. Any other drug treatment being received simultaneously on a long-term basis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cough Symptoms Score (CSS)
Cough Severity Index (CSI)
Leicester Cough Questionnaire (LCQ for cough & quality of life)
Laboratory Blood investigations : TLC. DLC. ESR, FBS, SGPT, SGOT, S.creatinine, Blood urea 		 baseline, day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Global patient assessment   day 7 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   21/10/2024 
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="4"
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   Kasa is the most common acute respiratory disease with global prevalence which results from vitiation of Pranavaha srotas. The disease if not treated in time may progress to lower respiratory tract leading to hemoptysis, high grade fever and dyspnoea. Large number of drugs are available to treat the condition with varying degrees of success although recurrence remains a major concern especially in the post-COVID era. The objective of this trial is to evaluate safety and efficacy of Zandu Ayurvedic cough syrup for kasa in clinical set up. The site of this study will be OPD of Kayachikitsa and Rog Nidan departments of Uttarakhand Ayurved University Hopsital, Dehradun.  The safety and toxicity study of this drug has already been established through various scientific parameters on rodents.    
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