CTRI Number |
CTRI/2023/04/051273 [Registered on: 03/04/2023] Trial Registered Prospectively |
Last Modified On: |
25/03/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Other |
Public Title of Study
|
Ayurvedic treatment for allergic rhinitis using Ayurvedic medicine. The treatment consists of taking Haridrakhanda orally and using Anu Taila Nasya (an oil) with and without Saraladi Dhoomapana (a type of steam inhalation). |
Scientific Title of Study
|
Efficacy of Haridrakhanda Orally and Anu Taila Nasya with and without Saraladi Dhoomapana in the management of Vataja Pratishyaya (Allergic Rhinitis)- An Open Labelled Randomized Comparative Clinical Trial. |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nisha M Vachhani |
Designation |
MS 1st year |
Affiliation |
Institute of Teaching and Research in Ayurveda |
Address |
4th floor,Department of Shalakya Tantra,I.T.R.A.,Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
9998725805 |
Fax |
|
Email |
nishavachhani548@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
DrRSUnadkat |
Designation |
M.S.(Ayu),Ph.D. |
Affiliation |
Institute of Teaching and Research in Ayurveda |
Address |
4th floor,Department of Shalakya Tantra,I.T.R.A.,Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
9427242598 |
Fax |
|
Email |
drrajshreeunadkat@yahoo.com |
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Details of Contact Person Public Query
|
Name |
DrRSUnadkat |
Designation |
M.S.(Ayu),Ph.D. |
Affiliation |
Institute of Teaching and Research in Ayurveda |
Address |
4th floor,Department of Shalakya Tantra,I.T.R.A.,Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
9427242598 |
Fax |
|
Email |
drrajshreeunadkat@yahoo.com |
|
Source of Monetary or Material Support
|
Institute of Teaching & Research in Ayurveda,Jamnagar,Gujarat,361008. |
|
Primary Sponsor
|
Name |
I.T.R.A.,Jamnagar |
Address |
I.T.R.A.,Jamnagar,Gujarat Pin code 361008,India |
Type of Sponsor |
Research institution and hospital |
|
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 |
Nisha M Vachhani |
Institute of Teaching and Research in Ayurveda |
4th floor, Department of Shalakya Tantra, I.T.R.A,Jamnagar Jamnagar GUJARAT |
9998725805
nishavachhani548@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institution Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hridrakhanda, Reference: Bhaishajyaratnavali chikitsa prakaran 55/13, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Luckwarm water), Additional Information: - | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtang hrdayam, Procedure details: PROCEDURE OF NASYA
Poorva Karma:
After evacuating the natural urges like urine and faeces, the patient will be advised to wash the
face and mouth with lukewarm water. Patient will be given Abhyanga with Bala Taila and
Swedana with lukewarm water over Uttamanga.
Pradhana Karma:
The patient will be Asked to lie in supine position extending his/her arms and legs and head slightly
extended up to 45degree. Later tip of the nose will be drawn upward by Vamapradeshni (left index
finger) and) (1) Medicine Name: Anu Taila, Reference: Ashtang hrdayam Sutra sthan 20/38, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 21 Days | 3 | Comparator Arm | Procedure | - | dhUmapAnam, धूमपानमॠ| (Procedure Reference: Sushruta Samhita Uttara Tantra 24/33, Procedure details: The patient should sit in erect and comfortable posture and maintain a cheerful frame of mind and
carefully inhale the medicinal fumes with his eyes cast down straight towards the ground.
• Dhooma Varti of 8 Angula Pramana should dip into ghrita and lighted. It should then put into the
Dhooma Netra of 24 Angula Pramana at its posterior end. patient should inhale three puffs of smoke
coming out from anterior end of Dhoomanetra through one nostril while other is closed and exhale
throug) (1) Medicine Name: Saraladi Dhoomapana, Reference: Sushruta Samhita Uttara Tantra 24/33, Route: Nasal, Dosage Form: Varti/ Suppository, Dose: 0(NA), Frequency: od, Duration: 21 Days |
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Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1.Patient between age group of 18 and 50 years.
2.The diagnosis of the disease shall be done with
signs and symptoms of Vataja Pratishyaya
(Allergic Rhinitis) i.e., Gala-Talu-Austha Shosha
(Dryness), Svaropaghata (Hoarsness of voice),
Kshavthu (Sneezing), Nasa Srava (Nasal
discharge), Nasaavrodha (Nasal obstruction).
|
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ExclusionCriteria |
Details |
1.Patient below 18 and above 50 years.
2.Cases which require surgical intervention like
Nasal polyps would be excluded.
3.Patients suffering from any chronic debilitating
disease like Tuberculosis, Diabetes Mellitus,
Asthma and other respiratory or nasal problems.
•Pregnant ladies and lactating mothers.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1) ANTERIOR RHINOSCOPIC EXAMINATION
2) NASAL ENDOSCOPY |
30 DAYS.
WILL BE ASSESED ON 0 DAY (BEFORE) AND 31ST DAY (AFTER) THE TREATMENT. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) KSHAVATHU (SNEEZING)
2) NASA SRAVA (NASAL DISCHARGE)
3) NASA AVARODH ( NASAL OBSTRUCTION)
4)KANDU (ITCHING IN EYE, PALATE AND THROAT) |
30 DAYS.
WILL BE ASSESED ON 0 DAY (BEFORE) AND 31ST DAY (AFTER) THE TREATMENT. |
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Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/05/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Introduction:Many research works have been carried out on Vataja Pratishyaya (Allergic Rhinitis) in Ayurveda and also in contemporary system of medicine, Vataja Pratishyaya (Allergic Rhinitis) still remains as a hazardous problem as it has more chances of recurrent episodes and serious complications. Haridrakhanda has Rasayana and Rogahara property. It may give an immune modulator effect which will be effective in the management of Vataja Pratishyaya (Allergic Rhinitis). Nasya with Anu Taila will have a great effect on symptoms of Pratishyaya, as Nasa is considered as direct gateway to the Shirah. Dhoomapana is one of the best therapies for diseases of Supra clavicular region specially Vata Kapha predominancy. So, the study has been planned to find out the management from the ancient texts which is effective and cheap. Information on the Trial procedure and Drug: Here in Group A, we are giving 6gm of Haridrakhanda twice a day with lukewarm water before meal, 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days with interval of 3 days) followed by Saraladi Dhoomapana 9 puffs in each nostril. In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days each with interval of 3 days). We assure that we will prepare formulations with as per S.O.P in the Pharmacy of I.T.R.A. Description of the Process: In present study, participants who will be clinically diagnosed and confirmed cases of Vataja Pratishyaya (Allergic Rhinitis) enlisted in inclusion criteria will be enrolled, minimum 30 patients and will be divided in to 2 groups by computer generated randomization technique, having minimum 15 patients in one group. In Group A, they will be given 6gm of Haridrakhanda twice a day with lukewarm water before meal, 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days with interval of 3 days) followed by Saraladi Dhoomapana 9 puffs in each nostril. In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days each with interval of 3 days) Follow-up: Follow up will be for one month duration at interval of 15 days. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: The efficacy of the therapy will be assessed on the basis of subjective criteria. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Rhinitis. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect. |