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CTRI Number  CTRI/2022/10/046709 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 12/10/2022
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   To see the changes in long standing sinusitis by application of Ayurveda nasal drops and tablet.  
Scientific Title of Study   A Randomized Controlled Comparative Clinical Trial to Evaluate the Efficacy of Lakshmivilasa Rasa and Shadbindu Taila Prathimarsa Nasya in Chronicrhinosinusitis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Remya A R 
Designation  PhD Scholar 
Affiliation  Banaras Hindu University 
Address  PhD Scholar Department of Shalakyathantra Faculty of Ayurveda IMS BHU
PhD Scholar Department of Shalakyathantra Faculty of Ayurveda IMSBHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9495232752  
Fax    
Email  drremyarajendran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B Mukhopadhyay MD Ay PhD D op 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Professor and HOD Department of Shalakyathantra Faculty of Ayurveda IMs BHU
Professor and HOD Department of Shalakyathantra Faculty of Ayurveda IMs BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9495232752  
Fax    
Email  drbijoy123@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Remya A R 
Designation  PhD Scholar 
Affiliation  Banaras Hindu University 
Address  PhD Scholar Department of Shalakyathantra Faculty of Ayurveda IMSBHU
PhD Scholar Department of Shalakyathantra Faculty of Ayurveda IMSBHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9495232752  
Fax    
Email  drremyarajendran@gmail.com  
 
Source of Monetary or Material Support  
CCRAS(Central Council for Research in Ayurvedic Sciences) Director Genreral Institutional Area Opp. D Block, Janakapuri New Delhi, 110058 
 
Primary Sponsor  
Name  CCRAS 
Address  Director General CCRAS Institutional Area Opp D Block Janakapuri Newdelhi 110058 
Type of Sponsor  Research institution 
 
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 
Remya A R  Sir Sunderlal Hospital  Department of Shalakyathantra Faculty Of Ayurveda OPD No 13 IMS, BHU
Varanasi
UTTAR PRADESH 		 9495232752

drremyarajendran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS, BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Lakshmivilasarasa, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Rasayoga, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: -
2Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtanga Sangraha, Procedure details: 3 drops of medicines will be instilled into each nostrils for 30 dayas, in morning 8.00am before food.)
(1) Medicine Name: Shadbindu taila, Reference: Bhaishajyaratnavali, Route: Nasal, Dosage Form: Taila, Dose: 3(drops), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Chronic Rhinosinusitis
2. Patients in the age group of 18 to 60 years  
 
ExclusionCriteria 
Details  1. chronic debilitating disease like CA, TB, AIDS.
2. Complicated sinusitis.
3. Allergic and fungal rhinosinusitis, patients with lower respiratory infection.
4. Cases which require surgical treatment.
5. Pregnant and lactating women.
6. Congenital malformation of nostrils as congenital choanal atresia, nasal glioma.
7. Patients with history of major brain surgery.
8. Patients with history of malignant hypertension and status asthmaticus.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relieve in signs and symptoms of Chronic Rhinosinusitis based on subjective parameters like nasal discharge, nasal obstruction, headache and heaviness of head, loss of sense of smell, post nasal drip and objective parameters like nasal endoscopy, CT scan of PNS, palpation of sinus.  Patients will be assessed on 30th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence of the disease  Assessment will be done for 3 consecutive months after stopping the medicines, in an interval of 1 month.  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/11/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chronic sinusitis is an inflammatory process that involves the paranasal sinuses and persists for 12 weeks or longer. It is often presented as chronic rhinosinusitis (CRS Chronic sinusitis has similarities with sannipāthika prathisyāya having kapha vātha doṣa predominance. Lakshmivilāsa rasa (Nāradīya) is mentioned in Bhaiṣajyaratnāvali, rasāyanādhikāra which is kapha vāthara and having rasāyana properties. Shadbindu taila, mentioned in Bhaiṣajyaratnāvali in Shirorogādhikāra is Vātha kapha samana and helps in expulsion of doṣas from Ṣiras. The patients diagnosed with Chronic rhinosinusitis fulfilling inclusion and exclusion criteria will be assigned into Study group and Control group randomly by computer generated block randomization. Each group comprise 35 patients. Study group will receive Lakshmivilāsa Rasa 1 tablet (250 mg) bd with honey, after food and Shadbindu taila as Prathimarsa nasya 3 drops in each nostrils at 8.00am before food, for one month. Control group will be given Amoxicillin clavulanate 1 tablet (625mg) tds, after food for 7 days, Oxymetazoline nasal spray 2 puffs twice daily for 10 days and steroid nasal spray (fluticasone) 2 sprays in each nostril for one month. The study will be comparative, RCT. The patients will be assessed based on subjective and objective parameters and follow up for 3 consecutive 3 months after stopping the medicines, in an interval of one month. Subjective parameters will be assessed based on Nasal Signs and Symptoms Score (NSSS) and 4 point verbal scale; just before commencing treatment, after treatment and during follow up. Objective parameters include Nasal endoscopy, CT scan, and culture sensitivity test, assessement on before treatment and after treatment. The data collected will be analysed statistically by using appropriate test.

 
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