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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   
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  
 
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  
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (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
3Comparator ArmProcedure-dhUmapAnam, धूमपानम् (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
 
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).

 
 
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.
 
 
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. 
 
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. 
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