| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J329||Chronic sinusitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Flucticasone Furoate | One puffs into each nostril every 12 hour daily | | 2 | Intervention Arm | Procedure | - | 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)
| | 3 | Intervention Arm | Drug | Classical | | (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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