| CTRI Number |
CTRI/2024/04/065329 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic treatment for allergic rhinitis using Ayurvedic medicine, The treatment consists of taking Haridrakhanda orally with and without Shunthyadi taila nasya |
|
Scientific Title of Study
|
Efficacy of Haridrakhanda orally with and without shunthyadi Taila Nasya in the management of Vataja Pratishyaya(Allergic Rhinitis)- An open Labelled Randomized comparative clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarita M Sosa |
| Designation |
MS Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor
Department of Shalakya Tantra ITRA Jamnagar361008
Jamnagar
GUJRAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9714450530 |
| Fax |
|
| Email |
saritabams170299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Unadkat |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor
Department of Shalakya Tantra ITRA Jamnagar361008
Jamnagar
GUJRAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427242598 |
| Fax |
|
| Email |
drrajshreeunadkat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R S Unadkat |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th floor
Department of Shalakya Tantra ITRA Jamnagar361008
Jamnagar
GUJRAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427242598 |
| Fax |
|
| Email |
drrajshreeunadkat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching & Research in Ayurvrda, Jamnagar, 361008 |
|
|
Primary Sponsor
|
| Name |
ITRA Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda, Opposite Reliance Mart,Jamnagar-361008, Gujra, 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 |
| DrSarita M Sosa |
Institute of Teaching and Research in Ayurveda |
OPD-4 Shalakya tantra Depatment Institute of Teaching and Research in Ayurveda Opposite B Division Police Station 361008 Jamnagar
Gujrat
Jamnagar
GUJARAT |
9714450530
saritabams170299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee, Institute of Teaching and Research in Ayurveda |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi taila, Reference: Sushruta Samhita, Uttartantra Vol 1, ch 40, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Bhaishajya Kal: 30 Days, Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridrakhanda , Reference: Bhaishjyaratnavali , Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Paients between age group of 18 and 50years.The diagnosis of the disease of Vataja Paratishyaya (Allergic Rhinitis) i.e. Gala-Talu-Oshtha shosha(Dryness), Svaropghata(Hoarseness of voice), Kshavathu(Sneezing), Nasa Srava(Nasal discharge) and Nasavarodha(Nasal obstruction) |
|
| ExclusionCriteria |
| Details |
Patients below 18 and above 50years.
1.Cases which require surgical intervention like polys would be excluded.
2.Patients suffering from any chronic debilating disease like Tuberculosis, Diabetes Mellitus, Asthma and other Respiratory or Nasal problems.
3.Patient having other type of rhinitis will be excluded on clinical feature and blood reports. Patients taking any steroid more than 1week |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in subjective and objective criterias assessed |
4-8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prolonged effect of ayurvedic intervention in thé management of Vataja Pratishyay(Allergic Rhinitis) |
4-8weeks |
|
|
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)
|
15/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many research work have been carried out on Vataja Pratishyaya(Allergic Rhinitis) in Ayurveda and in contemporary system of medicine, Vataja Pratishyaya(Allerigc Rhinitis) still remain as a hazardous problem as it has more chances of recurrent episodes and serious complication. Haridrakhanda has Rasayana and Rogahara property. It may gives an immune modulator effect which will be effect on symptoms of Pratishyaya(Allergic Rhinitis). Nasya with Shunthyadi Taila will have great effect on symptoms of Pratishyaya, as Nasa is considered as direct gateway to the shirah. 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 In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and 6drops of Shunthyadi Taila Nasya in each nostril in morning(3 sitting of Nasya for 7 days each with interval of 3days). We assure that we will prepare formulation with as per S.O.P. in the Pharmacy of I.T.R.A. Description of the Process: In pesent 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 gnerated randmozation 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, In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and Shunthyadi Taila Nasya in each nostril in morning(3 sitting of Nasya for 7days each with interval of 3days) 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 |