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CTRI Number  CTRI/2025/07/091420 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see the efficacy of Ayurveda Management in Chronic Rhinosinusitis 
Scientific Title of Study   Evaluation of efficacy and safety of Shadbindu Taila Marsha Nasya and Chitraka Haritaki Avaleha in Chronic Rhinosinusitis: A Randomized Controlled Multicenter Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Mata 
Designation  Research Officer Ay 
Affiliation  Central Ayurveda Research Institute New Delhi 
Address  Central Ayurveda Research Institute Punjabi Bagh Road no 66 Room no 202 New Delhi India

West
DELHI
110026
India 
Phone  08866014946  
Fax    
Email  shwetamatadr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana Kumari 
Designation  Research Officer Ay 
Affiliation  RARI Patna 
Address  “D” Block, RMRIMS Building, Agam Kuan, Patna-800007 (Bihar)

Patna
BIHAR
800007
India 
Phone  7046074206  
Fax    
Email  archana06bly@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pallavi Mundada 
Designation  Research Officer Ay 
Affiliation  CCRAS Delhi 
Address  61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058

West
DELHI
110058
India 
Phone  8329892061  
Fax    
Email  pallavimundada86@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences 61-65 Institutional Area Janakpuri New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shweta Mata  Central Ayurveda Research Institute  Room no. 202, Central Ayurveda Research Institute New Delhi Road no. 66, punjabi bagh west, Delhi, India
West
DELHI 
08866014946

shwetamatadr@gmail.com 
Dr Archana Kumari  Regional Ayurveda Research Institute  Room no. 4, “D” Block, RMRIMS Building, Agam Kuan, Patna-800007 (Bihar)
Patna
BIHAR 
7046074206

archana06bly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Flucticasone FuroateOne puffs into each nostril every 12 hour daily
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: AH Sutrasthana 20, Procedure details: Nasya to be given for 4 sittings,seven days in each, with the interval of seven days between each sitting. Nasya to be given in each nostril in lying down position early morning in empty stomach after taking Sthanik Abhyanga with Bala Taila (AFI part I) for 5 minutes followed by Bashpa Sweda for 5 minutes. Duration of therapy : 28 days of therapy and 28 days interval, so the total duration of therapy is 56 days)
3Intervention ArmDrugClassical(1) Medicine Name: Chitraka Haritali, Reference: API Part II Vol. I, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: NA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between the age group of 18
to 60 years.
2. Patients suffering with Pinasa
(Chronic Rhinosinusitis) who are
fulfilling the diagnostic criteria based
on American system of Academy
(AAO-HNS) will be selected for the
present study.
(a). Twelve weeks or longer of two or
more of the following signs and
symptoms:
Mucopurulent drainage (anterior,
posterior or both),
Nasal obstruction (congestion),
Facial pain-pressure-fullness
Decreased sense of smell
(b). AND inflammation is
documented by one or more of the
following findings:
Purulent (not clear) mucus or edema
in the middle meatus or anterior
ethmoid region,
Polyps in nasal cavity or the middle
meatus, and/or Radiographic imaging
showing inflammation of the
paranasal sinuses
3. Willing to participate in study. 
 
ExclusionCriteria 
Details  1. Patients below 18 and above 60 years of
age.
2. History of chronic nasal or upper
respiratory tract symptoms or disorders
other than Chronic Rhinosinusitis.
3. Patients suffering with
tonsillitis/adenoids.
4. Patients who are on treatment with H1
antihistamine medication, non-steroidal
analgesics, Leukotriene antagonists.
5. Cases of fungal sinusitis (On Non-
Contrast CT-PNS; Hypoattenuating
mucosal thickening, intranasal/
intrasinus soft tissue attenuation/
opacification, associated osseous
erosions, hyperdense fungal hyphae
within sinus).
6. Presence of secondary immune
deficiency state: HIV, organ transplant,
Malignancy, Treatment with
corticosteroids.
7. Known cases of Hepatitis B and C
positive.
8. Pregnancy & Lactation.
9. Patients suffering from chronic
debilitating disease like tuberculosis,
rheumatoid arthritis, Pulmonary
Dysfunction (Bronchial Asthma and / or 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome: The change in terms of
SNOT-22 score (Sino-Nasal Outcome Test) 
On base line, 56th day, 84th day 
 
Secondary Outcome  
Outcome  TimePoints 
The change in RSDI score (Rhinosinusitis Disability Index)   On base line 56th day 84th day 
Lund-Mackay scores of computed tomography (CT) scan of paranasal sinuses  On base line, 56th day 
Change in the laboratory safety parameters from baseline   baseline, 56TH Day 
Dependence on rescue medicines  On base line, 14th day, 28th day, 42th day, 56th day 
Incidence of treatment emergent adverse events  On base line, 14th day, 28th day, 42th day, 56th day 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   05/08/2025 
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="2"
Months="0"
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  

The prevalence of chronic rhinosinusitis (CRS) measured in epidemiologic studies is 5% to 12%. Chronic Rhinosinusitis is one of the important global health problems defined as inflammation of the mucous membrane of the nose and paranasal sinuses. Chronic rhinosinusitis refers to a condition that lasts at least 12 weeks, despite attempts to treat it, and causes at least two of the symptoms; nasal congestion, mucus discharge from the nose or mucus that drips down the back of the throat, facial pain, pressure, or fullness, a decreased sense of smell. The proximity of the brain to the sinuses makes the most dangerous complication of Chronic Rhinosinusitis, particularly involving the frontal and sphenoid sinuses, infection of the brain by   the invasion of anaerobic   bacteria through the   bones   or   blood vessels. Abscesses, meningitis and other life-threatening conditions may result. In extreme cases, the patient may experience mild personality changes, headaches, altered consciousness, visual problems, seizures, coma and possibly death. The treatment strategy for Chronic Rhinosinusitis mainly includes the use of topical decongestants, saline nasal drops, nasal saline irrigations, nasal steroids, antihistamines, antibiotics and in some cases surgical interventions. Even though not a life-threatening condition it produces difficulty in carrying out day to day activities and greatly affects the quality of life. Pinasa Roga is one such chronic disease which affects the nose and nasal passages. Pinasa is due to vitiated Vata Kapha, with Nasaavarodha (Nasal obstruction), Nasashosha (dryness of the nose), Gandha agyana (abnormal perception of smell) as the characteristic symptoms. The various etiological factors mentioned (faulty life style & regimen) leads to Agnimandya and Aama which is the main causative factor for the disease. Ayurveda being a life science advocated preventive and curative measures for the treatment of various chronic diseases. Earlier researches have proved the effectiveness of Ayurvedic treatment in the management of Pinasa Roga. Chitraka Haritaki Lehya is mentioned in Nasarogadhikara Chikitsa in Chakradutta (58/31-33). Shadbindu Taila is medication described in Bhaishajyaratnavali Siroroga chikitsa Prakarana for the management of almost all Urdhajatrugata Rogas (65/81- 83). Total 160 patients (80 at each participating center) will be included in the study. The observations and discussion will be made according to statistical analysis on different clinical & objective parameters and scores of questionnaires (Chronic Rhinosinusitis Questionnaire). This study has been proposed to evaluate the efficacy and safety of Administration of Shadbindu Taila Marsha Nasya and Chitraka Haritaki Avleha in Chronic Rhinosinusitis.

 
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