| 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›yÄya (chronic rhinosinusitis) with oral medicines |
|
Scientific Title of Study
|
A CLINICO-COMPARATIVE STUDY OF NASYA KARMA WITH ṢAḌBINDU TAILA AND KAṬPHALA CŪRṆA IN THE MANAGEMENT OF DUṢṬAPRATIŚYĀYA (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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: DUSHTAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nAvanam, नावनमॠ| (Procedure Reference: Dr.R.Vidyanath Astanga Hradya Sutra Sthana 20/1 ,page number 312, Chaukhambha Surbharti PrakashanVaranasi,2016, Procedure details: purva karma UÌ„rdhvajatrugata Abhyaṅga with NaÌ„raÌ„yanÌ£a Taila(Daily) UÌ„rdhvajatrugata Svedana with Hot water bag (Daily) pradhan karma SÌ£adÌ£bindu Taila Nasya 6 drops in each nostril Paschat Karma Kavala with UsÌ£nÌ£odaka)) (1) Medicine Name: PathyÄdi kvÄtha, 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: SitopalÄdi CuÌ„rnÌ£a, 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 | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Dr.R.Vidyanath Astanga Hradya Sutra Sthana 20/1 ,page number 312, Chaukhambha Surbharti PrakashanVaranasi,2016., Procedure details: purva karma UÌ„rdhvajatrugata Abhyaṅga with NaÌ„raÌ„yanÌ£a Taila(Daily) UÌ„rdhvajatrugata Svedana with Hot water bag (Daily) pradhan karma Katphala CuÌ„rnÌ£a Nasya- one pinch in each nostril Paschat Karma Kavala with UsÌ£nÌ£odaka)) (1) Medicine Name: PathyÄdi kvÄtha , 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: SitopalÄdi CuÌ„rnÌ£a, 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 |
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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)
Kāsa (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.
|
|
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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 NÄsÄroga.
Untreated or improperly treated Pratiśyāya leads to chronic condition known
as Duṣṭa Pratiśyāya.
It is a Tridoṣaja Vyādhi 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), ÅširorujÄ (headache), Åširogaurava
(heaviness of head), Kāsa (coughing),
Kaphotkleśa (expectoration), Svarabheda
(hoarseness of voice).As
Duṣṭa Pratiśyāya is a chronic condition of Doṣa
accumulated particularly in Nāsā and Śiraḥa, which occurs
mainly due to Saṅga type of Srotoduṣṭi.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 Nāsā and Śirogata Doṣa
Duṣṭi. Sirovirecana type of Nasyas are preferred to
eliminate the accumulated Doá¹£Äs from Siraha Pradesa. Nasya
with Ṣaḍbindu Taila and Kaṭphala Cūrṇa cause Śirovirecana
and hence are mentioned in the treatment of Pratiśyāya 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 Kāyacikitsā, PañcaKarma and Department of Śālākya 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 PathyÄdi kvÄtha
40 ml/twice a day (empty
stomach) SitopalÄdi CuÌ„rnÌ£a-2gm twice a day with
Madhu in oral medicaments. Group A will be treated with Ṣaḍbindu Taila Nasya -6
drops in each nostril and Group B will be treated by Katphala Cūrṇa
Nasya- one pinch in each nostril followed by Ūrdhvajatrugata
Abhyaṅga with Nārāyaṇa Taila (Daily) and Ūrdhvajatrugata 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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