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CTRI Number  CTRI/2025/01/078925 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 12/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the effects of two Nasya Karma with Shadbindu Taila and Katphala Churna in the management of Dushá¹­apratiÅ›yāya (chronic rhinosinusitis) with oral medicines 
Scientific Title of Study   A CLINICO-COMPARATIVE STUDY OF NASYA KARMA WITH SÌ£ADÌ£BINDU TAILA AND KAṬPHALA CUÌ„RNÌ£A IN THE MANAGEMENT OF DUSÌ£TÌ£APRATIÅšYAÌ„YA (RHINOSINUSITIS) 
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 DEVARSH S JAYSWAL 
Designation  2nd year PG Scholar 
Affiliation  J S Ayurved mahavidyalaya 
Address  PG Department of panchakarma J S Ayurved mahavidyalaya Collage road Nadiad

Kheda
GUJARAT
387001
India 
Phone  9638976462  
Fax  0  
Email  devarshjayswal9358@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Kalapi B Patel 
Designation  HOD and Professor  
Affiliation  J S Ayurved mahavidyalaya 
Address  PG Department of panchakarma J S Ayurveda mahavidyalaya Collage road Nadiad,Kheda,Gujrat,India 387001
PG Department of Panchakarma J S Ayurveda mahavidyalaya Collage road Nadiad,Kheda
Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Kalapi B Patel 
Designation  HOD and Professor  
Affiliation  J S Ayurved mahavidyalaya 
Address  PG Department of panchakarma J S Ayurved mahavidyalaya Collage road Nadiad
PG Department of panchakarma J S Ayurved mahavidyalaya Collage road Nadiad
Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurved teaching Pharmacy J S Ayurved Mahavidyalaya Nadiad,Kheda,Gujrat,India 387001 
 
Primary Sponsor  
Name  J S Ayurved Mahavidyalaya 
Address  PG Department of panchakarma J S Ayurved mahavidyalaya Collage road,Nadiad,Gujrat,India 387001 Nadiad,Kheda,Gujrat,India 387001 
Type of Sponsor  Research institution and hospital 
 
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 Devarsh  P D Patel Ayurveda Hospital  PG Department of panchakarma P D Patel Ayurved Hospital J S Ayurved mahavidyalaya Collage road Nadiad
Kheda
GUJARAT 
9638976462

devarshjayswal9358@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: DUSHTAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nAvanam, नावनम् (Procedure Reference: Dr.R.Vidyanath Astanga Hradya Sutra Sthana 20/1 ,page number 312, Chaukhambha Surbharti PrakashanVaranasi,2016, Procedure details: purva karma Ūrdhvajatrugata Abhyaṅga with Nārāyaṇa Taila(Daily) Ūrdhvajatrugata Svedana with Hot water bag (Daily) pradhan karma Ṣaḍbindu Taila Nasya 6 drops in each nostril Paschat Karma Kavala with Uṣṇodaka))
(1) Medicine Name: Pathyādi kvātha, Reference: DR.Sailaja Jivanprada Vyakhya Sarangadhara saamhita published by chaukhambha orientala 2011 Varansi, Madhyam Khanda Shirorogadhyaya 02/120, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: bd, Duration: 51 Days
(2) Medicine Name: Sitopalādi Cūrṇa, Reference: DR.Sailaja Jivanprada Vyakhya Sarangadhara saamhita published by chaukhambha orientala 2011 Varansi, Madhyam Khanda Shirorogadhyaya 02/120, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 51 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Dr.R.Vidyanath Astanga Hradya Sutra Sthana 20/1 ,page number 312, Chaukhambha Surbharti PrakashanVaranasi,2016., Procedure details: purva karma Ūrdhvajatrugata Abhyaṅga with Nārāyaṇa Taila(Daily) Ūrdhvajatrugata Svedana with Hot water bag (Daily) pradhan karma Katphala Cūrṇa Nasya- one pinch in each nostril Paschat Karma Kavala with Uṣṇodaka))
(1) Medicine Name: Pathyādi kvātha , Reference: DR.Sailaja Jivanprada Vyakhya Sarangadhara saamhita published by chaukhambha orientala 2011 Varansi, Madhyam Khanda Shirorogadhyaya 02/120, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(g), Frequency: bd, Duration: 51 Days
(2) Medicine Name: Sitopalādi Cūrṇa, Reference: DR.Sailaja Jivanprada Vyakhya Sarangadhara saamhita published by chaukhambha orientala 2011 Varansi, Madhyam Khanda Shirorogadhyaya 02/120, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 51 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfilling diagnostic criteria.
Kṣavathu (Paroxysmal Sneezing)
Nāsā Avrodha (Nāsāl Obstruction)
Nāsā Srāva (Rhinorrhea)
Śiraḥa Śūla (Headache)
Kanḍu (Itching in nose)
Kāsa (Coughing)
3) Age group between 18 to 60 years
 
 
ExclusionCriteria 
Details  1) Patients having previous history of nasal surgery.
2) Patients suffering from any other clinical conditions which can interfere the treatment i.e. epistaxis, carcinoma etc.
3) Clinical conditions contra-indications for Nasya Karma.
As per the classical Ayurvedic texts
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in sign symptoms of Dusta Partishyaya
Assessment parameter
Kṣavathu (Paroxysmal Sneezing)
Nāsā Avrodha (Nāsāl Obstruction)
Nāsā Srāva (Rhinorrhea)
Śiraḥa Śūla (Headache)
Kanḍu (Itching in nose)
KaÌ„sa (Coughing)  
The total duration of treatment will be 21 days. Patients will be followed up every 15 days up to 1 month after completion of the treatment for observation of further changes in signs and symptoms during follow-up period.
 
 
Secondary Outcome  
Outcome  TimePoints 
Remission in sign symptoms of Dusta Partishyaya
 
The total duration of treatment will be 21 days. Patients will be followed up every 15 days up to 1 month after completion of the treatment for observation of further changes in signs & symptoms during follow-up period.
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2025 
Date of Study Completion (India) 18/03/2027 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/03/2027 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

PratiÅ›yaÌ„ya is one among Nāsāroga. Untreated or improperly treated PratiÅ›yaÌ„ya leads to chronic condition known as DusÌ£tÌ£a PratiÅ›yaÌ„ya. It is a TridosÌ£aja VyaÌ„dhi and is closely resembling to Rhinosinusitis of conventional medicine. Characteristic features of DusÌ£tÌ£a PratiÅ›yaÌ„ya are NaÌ„saÌ„sraÌ„va (running nose), GhraÌ„noparodha (nasal obstruction or congestion), Åširorujā (headache), Åširogaurava (heaviness of head), KaÌ„sa (coughing), KaphotkleÅ›a (expectoration), Svarabheda (hoarseness of voice).As DusÌ£tÌ£a PratiÅ›yaÌ„ya is a chronic condition of Doá¹£a accumulated particularly in NaÌ„saÌ„ and ÅširahÌ£a, which occurs mainly due to Saṅga type of SrotodusÌ£tÌ£i.In Ayurveda nose is considered as gate way of head, Nasya is the therapeutic procedure in which the medicaments are administered through nasal route which will act on NaÌ„saÌ„ and Åširogata Doá¹£a DusÌ£tÌ£i. Sirovirecana type of Nasyas are preferred to eliminate the accumulated Doṣās from Siraha Pradesa. Nasya with SÌ£adÌ£bindu Taila and KatÌ£phala CuÌ„rnÌ£a cause Åširovirecana and hence are mentioned in the treatment of PratiÅ›yaÌ„ya in classical Ayurveda texts.Patient that fulfill the inclusion criteria of rhinosinusitis will be selected from O.P.D and I.P.D of Post Graduate Departments of KaÌ„yacikitsaÌ„, PañcaKarma and Department of ÅšaÌ„laÌ„kya Tantra, P.D. Patel Ayurvedic Hospital,Nadiad for the present study irrespective of age, sex, caste, religion etc.Both A and B group will be treated with Pathyādi kvātha 40 ml/twice a day (empty stomach) Sitopalādi CuÌ„rnÌ£a-2gm twice a day with Madhu in oral medicaments. Group A will be treated with SÌ£adÌ£bindu Taila Nasya -6 drops in each nostril and Group B will be treated by Katphala CuÌ„rnÌ£a Nasya- one pinch in each nostril followed by UÌ„rdhvajatrugata Abhyaṅga with NaÌ„raÌ„yanÌ£a Taila (Daily) and UÌ„rdhvajatrugata Svedana with hot water bag daily.The total duration of treatment will be 21 days. Patients will be followed up every 15 days up to 1 month after completion of the treatment for observation of further changes in signs and symptoms during follow-up period.



 



 

 
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