| CTRI Number |
CTRI/2023/05/053020 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Allergic Rhinitis through Ayurveda |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation on the Role of Panch Lavan Ghrit Nasya and Vachadi Potli Ghranam with or without Internal Goghritpan in Vataja Pratishyaya (Allergic Rhinitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrManoj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
| Address |
Room No 106 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996310888 |
| Fax |
|
| Email |
drmanojtanwar23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManoj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
| Address |
Room No 106 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996310888 |
| Fax |
|
| Email |
drmanojtanwar23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManoj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
| Address |
Room No 106 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996310888 |
| Fax |
|
| Email |
drmanojtanwar23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Ayush University Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Dr Himanshi |
| Address |
Shri Krishna Government Ayurvedic College And Hospital Kurukshetra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrHimanshi |
Shri Krishna Government Ayurvedic College and Hospital, Kurukshetra |
Room No. 54, Shalakya Tantra, Shri Krishna Ayurvedic Hospital
Kurukshetra
HARYANA |
8571911535
drhimanshi97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Shushrut Chikitsa 40, Procedure details: Patient is made to lie in supine position. Abhyanga of face is done for 5-7 mins and then nadiswedan will be done for 3 min. Nasya drops 6-8 drops per nostril will be administrated after that. Then Vachadi potli ghranan will be done 3 puffs per nostril. Patient will be given goghrit orally twice a day in 10gm dose)
(1) Medicine Name: Panchlavan ghrit, Reference: Chakradat samhita nasarogchikitsa 44/16, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 2 Weeks(2) Medicine Name: Vachadi potli, Reference: Yogratnakar nasarogchikitsa 6, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 3(NA), Frequency: od, Duration: 2 Weeks(3) Medicine Name: Goghrit, Reference: Shushrut uttartantra 24, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Shushrut chikitsa 40, Procedure details: Patient is made to lie in supine position. Abhyanga of face is done for 5-7 mins and then nadiswedan will be done for 3 min. Nasya drops 6-8 drops per nostril will be administrated after that. Then Vachadi potli ghranan will be done 3 puffs per nostril. )
(1) Medicine Name: Panchlavan ghrit, Reference: Chakradat samhita nasarogchikitsa 44/12, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 2 Weeks(2) Medicine Name: Vachadi potli, Reference: Yogratnakar nasarogchikitsa 6, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 3(NA), Frequency: od, Duration: 2 Weeks |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with signs and symptoms of Vataja Pratishyaya mentioned in Ayurvedic Classics and Allergic Rhinitis according to Allopathic science.
2.Patients willing to participate in the study.
3.Patient of either sex.
4.Patients between the age group of 16– 60 yrs.
|
|
| ExclusionCriteria |
| Details |
1.Patients having history of systemic disease as Diabetes Mellitus, Hypertension, Hypothyroidism.
2.Patients suffering from gross deviation of nasal septum, nasal tumours, adenoid hyperplasia, nasal polyps etc.
3.Pregnant women.
4.Patients not fit for Nasya therapy and Ghritpana. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the symptoms like Sneezing, Rhinorrhea, Stuffiness of nose |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To See change in AEC, ESR levels
To decrease the grade of severity of disease
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The increasing prevalence of Allergic Rhinitis globally is a matter of concern. Worldwide, allergic rhinitis affects between 10% to 30% of the population. Worldwide sensitization (IgE antibodies) to foreign protiens in the environment is present in upto 40% of the population. About 20-30% of Indian population suffer from at least one allergic disease where allergic rhinitis alone constitutes about 55% of all allergies. This region of Haryana is Semi-arid & dusty. Allergic Rhinitis is quite common in this area. Patients of Vataja Pratishyaya(Allergic Rhinitis) after having treatment from various Many treatment modalities are explained in Allopathic science like Corticosteroids, Anti-Allergic drugs, Inhalers, Antihistamines etc. but none of them are totally effective in curing the disease as well as preventing its recurrence, more over they have their own side effects like Rhinitis medicamentosa, fungal growth due to Topical steroids etc. . Hence there is a need for more effective, safe, treatment modality which is especially beneficial in chronic cases to treat this problem from grass root level. Nasya Karma is considered as the main Shodhana therapy to expel Doshas from the Shira. Both Bringhan and Rechan Nasya are very beneficial for removing the Doshas from the body especially in chronic cases as the Doshas are lodged in different parts of Urdhavjatru. Moreover, in Vataja Pratishyaya, as there is Vimarga gamana of Vata Dosha, Panchlavan Ghrit Nasya with Vachadi Potli Ghranam does Shira shodhana and Vata Anulomana and hence it can be beneficial in this disease. In order to promote Shamana effect, Goghrit is selected for internal administration in patients suffering from Vataja Pratishyaya (Allergic Rhinitis). Hence this study entitled “A Randomized Comparative Clinical Evaluation on the Role of Panchlavan Ghrit Nasya and Vachadi Potli Ghranam with or without Internal Goghritpan in Vataja Pratishyaya (Allergic Rhinitis)†is selected for providing a better relief without any recurrence and in order to find an effective solution to the above problem for curing the disease from its root cause. For this study total 60 patients will be taken, 30 in each group. First group will be given Panchlavan Ghrit Nasya and Vachadi Potli Ghranam with internal Goghritpa( 10-20 ml, Twice a day) administration for 30 days and other group will be given Panchlavan Ghrit Nasya and Vachadi Potli Ghranam without administration of internal Goghritpan for 30 days period, after that three follow ups will be done at 50th, 60th and 90th day and changes will be noted. |