CTRI Number |
CTRI/2022/07/043987 [Registered on: 13/07/2022] Trial Registered Prospectively |
Last Modified On: |
01/11/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
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Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
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Study of the effect of Shigru Taila Nasya,Gaganesvara Rasa and Haritakyadi Churna Virechana in Allergic Rhinitis. |
Scientific Title of Study
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A Randomized Clinical Trial on the Role of Shigru Taila Nasya and Gaganesvara Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference To Allergic Rhinitis. |
Trial Acronym |
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Secondary IDs if Any
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Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Manish Kumar Varshney |
Designation |
PG Scholar |
Affiliation |
National Institute of Ayurveda Deemed To Be University Jaipur |
Address |
PG Department Of Shalakaya tantra National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Jaipur Madhav Vilas Palace, Jorawar Singh Gate, Jaipur Jaipur RAJASTHAN 302002 India |
Phone |
9784596886 |
Fax |
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Email |
varshney43manish@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
Prof Shamsa Fiaz |
Designation |
Prof. and Head of Department Shalakya Tantra |
Affiliation |
National Institute of Ayurveda Deemed To Be University Jaipur |
Address |
PG Department Of Shalakaya tantra National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Jaipur PG Department Of Shalakaya tantra, Room no 309, National Institute Of Ayurveda, Deemed To Be University, Madhav Vilas Palace, Jorawar Singh Gate, Jaipur Jaipur RAJASTHAN 302002 India |
Phone |
8764009846 |
Fax |
|
Email |
shamsa_fiaz@yahoo.com |
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Details of Contact Person Public Query
|
Name |
Manish Kumar Varshney |
Designation |
PG Scholar |
Affiliation |
National Institute of Ayurveda Deemed To Be University Jaipur |
Address |
PG Department Of Shalakaya tantra National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Jaipur Madhav Vilas Palace Jorawar Singh Gate Jaipur Jaipur RAJASTHAN 302002 India |
Phone |
9784596886 |
Fax |
|
Email |
varshney43manish@gmail.com |
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Source of Monetary or Material Support
|
National institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 |
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Primary Sponsor
|
Name |
National institute Of Ayurveda Deemed To Be University Jaipur |
Address |
Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 |
Type of Sponsor |
Research institution and hospital |
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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 |
DrManish Kumar Varshney |
National Institute Of Ayurveda Deemed To Be University Jaipur |
Deparment Of Shalakya Tantra Madhav Vilas Palace Jorawar SIngh Gate Jaipur Jaipur RAJASTHAN |
9784596886
varshney43manish@gmail.com |
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Details of Ethics Committee
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No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
NIA IEC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, |
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Intervention / Comparator Agent
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sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gaganesvara rasa, Reference: Sahasrayogam Rasa yoga prakarana 22/7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: Starting along with Nasya Karma | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: AshtangHridaya sutra sthana20/9-10, Procedure details: Patients will be advised Nasya on empty stomach by performing Abhyanga on neck, face, forehead followed by hot water fomentation. In Pradhana Karma, Nasya drug in the dose of 6 drops per nostril will be administered followed by Paschat Karma with Haridra stick Dhoomapana and Saindhava Jala Kavala following all SOP’s related to Nasya Karma. ) (1) Medicine Name: Shigru Taila , Reference: Vangasen samhita Nasarogadhikar-102, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 14 Days | 3 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Susruta samhita utter tantra 24/20, Procedure details: Sarvanga Abhyanga with Dashamoola taila and Bhaspa sweda will be done for only one day.
2nd day in morning 6 to 10 gms of Haritakyadi Churna Virechana (depending upon type of kostha) will be administered with luke warm water on empty stomach.
Samsarjana Karma -3 to7 days- based on Koshta Shuddhi.
) (1) Medicine Name: Haritakyadi churna , Reference: Charak Samhita chikitsa sthanam rasayana-1/25-28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 1 Days |
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Inclusion Criteria
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Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
(1) Patients willing to participate in the study
(2) Patients between the age group of 18– 60 yrs.
(3) Patients presenting with signs and symptoms of Vataja Pratishyaya mentioned in Ayurvedic Classics and Allergic Rhinitis according to Allopathic science.
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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 Virechana.
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Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Change in visual analogues scale. |
30 days |
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Secondary Outcome
|
Outcome |
TimePoints |
Change in nasal congestion and turbinate hypertrophy. |
30 days |
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Target Sample Size
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Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
08/12/2022 |
Date of Study Completion (India) |
17/06/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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The increasing prevalence of Allergic Rhinitis has affected global health problem effecting a quarter of the world population. Over 400 million people suffer from Allergic Rhinitis around the world and to a large extent it remains under diagnosed and under treated. About 20-30% of Indian population suffer from at least one allergic disease where allergic rhinitis alone constitutes about 55% of all allergies. Allergic Rhinitis symptoms result in sleep disturbances, fatigue, depressed mood and cognitive functions which impairs quality of life and productivity. 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. Although innumerable preparations are available in modern science, no drug ensures complete relief without any side effects and the chances of recurrences are relatively high. 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. Kostha suddhi is very beneficial for removing the Doshas from the body especially in chronic cases as the Doshas are lodged in different parts of body. Sarvanga Abhyanga and Swedana help in diverting the Doshas from Shakhas to Koshta which can then can be expelled through Haritakyadi Churna Virechana. Moreover, in Vataja Pratishyaya, as there is Vimarga gamana of Vata Dosha, Virechana does Shareera shodhana and Vata Anulomana and hence it can be beneficial in this disease. Along with that, Nasya Karma is considered as the main Shodhana therapy to expel Doshas from the Shiras. Hence Shigru Taila Nasya has been selected which is considered as a drug of choice in Vataja Pratishyaya. In order to promote Shamana effect, Gaganesvara rasa is selected for internal administration in patients suffering from Vataja Pratishyaya (Allergic Rhinitis). Hence this study entitled,A Randomized clinical Trial on the Role of Shigru Taila Nasya and Gaganesvara Rasa with or without Haritakyadi churna Virechana in Vataja Pratishyaya with special reference To Allergic Rhinitis is selected for providing a better relief without any recurrence in order to find an effective solution to the above problem for curing the disease from its root cause. Aim and Objectives Aim To evaluate the efficacy of Shigru Taila Nasya, Gaganesvara Rasa with and without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference to Allergic Rhinitis Objectives · To evaluate the efficacy of Shigru Taila Nasya and Gaganesvara Rasa orally with Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference to Allergic Rhinitis. · To evaluate the efficacy of Shigru Taila Nasya and Gaganesvara Rasa orally without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference to Allergic Rhinitis Study Medication: Group A - 15 patients of Vataja Pratishyaya will be given Haritakyadi Churna Virechana followed by Shigru Taila Nasya along with internal administration of Gaganesvara Rasa. Group B – 15 patients of Vataja Pratishyaya will be given Shigru Taila Nasya and internal administration of Gaganesvara Rasa. · · Treatment Plan : | Treatment | Duration | Follow up | Group- 1 | Koshta Shuddi- Sarvanga Abhyanga and Swedana for one day followed by 6 to 10 gms of Haritakyadi Churna Virechana given with luke warm water Marsha Nasya with Shigru Taila in dosage of 6 drops each nostril | 3 to 7 days as per Koshta shuddhi 14 days (2 sittings each of 7 days with an interval of 7 days in between). | Once in 15 days 2 follow ups after treatment | | Gaganesvara Rasa 250 mg b.d. with honey | 21 days Starting along with Nasya karma | Group- 2 | Marsha Nasya with Shigru Taila in dosage of 6 drops in each nostril. | 14 days (2 sittings each of 7 days with an interval of 7 days in between). | | Gaganesvara Rasa 250 mg b.d. with honey | 21 days, starting along with Marsha Nasya. | | · Assessment Criteria: - To assess the relief in signs and symptoms mentioned below, a specific scoring pattern will be adopted. a. ShirohShoola /Shirogaurava (Headache) b. Tanusravapravartan (Rhinorrhoea) c. Kshavathu (Sneezing) d. Aanaddha Nasa (Nasal obstruction) e. Swaropaghata (Hoarseness of voice) f. Kasa (Cough) g. Kandu (Itching) h. Nasal Congestion. i. Turbinate hypertrophy ◠Laboratory Investigations – Following investigations will be carried out before and after trial. 1. Absolute Eosinophil Count(AEC) 2. CBC 3. ESR 4. Allergen- specific Ig E Antibody Test. Hypothesis:- Null Hypothesis- H0 There is no difference in the effect of Shigru Taila Nasya, Gaganesvara Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference To Allergic Rhinitis. Alternate Hypothesis- There is difference in the effect of Shigru Taila Nasya, Gaganesvara Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with Special reference To Allergic Rhinitis.
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