CTRI Number |
CTRI/2018/03/012589 [Registered on: 15/03/2018] Trial Registered Prospectively |
Last Modified On: |
14/03/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Allergic cold and cough |
Scientific Title of Study
|
Comparative Randomized Clinical Trial to Evaluate the Efficacy of Marsha and Pratimarsha Nasya with Haridrakhanda orally in the management of Vataja Pratishyaya with respect to Allergic Rhinitisâ€
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Radha kumari |
Designation |
PG Scholar |
Affiliation |
All India Institute of Ayurveda |
Address |
OPD 103 hospital block
All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi-110076 OPD 103 hospital block
All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, South DELHI 110076 India |
Phone |
9455876335 |
Fax |
|
Email |
drradhakumari2015@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pankaj Kundal |
Designation |
Assistant professor |
Affiliation |
All India Institute of Ayurveda |
Address |
OPD 101 hospital Block
All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi OPD 101 hospital Block
All india institute of ayurveda, shalakya dept. gautampuri sarita vihar mathura road South DELHI 110076 India |
Phone |
7291887810 |
Fax |
|
Email |
drpankajkundal@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Narayan Bavalatti |
Designation |
Assistant professor |
Affiliation |
All India Institute of Ayurveda |
Address |
opd 102 hospital block
All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi All india institute of ayurveda, shalakya dept. gautampuri sarita vihar, mathura road, New delhi-110076 South DELHI 110044 India |
Phone |
9650715615 |
Fax |
|
Email |
eyenimi@gmal.com |
|
Source of Monetary or Material Support
|
All india institute of ayurveda Gautampuri Sarita vihar New Delhi-110076 |
|
Primary Sponsor
|
Name |
All institute of ayurveda |
Address |
All india institute of ayurveda, gautampuri, sarita vihar, mathura road, ned delhi-110076 |
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 |
Dr Radha kumari |
All india institute of Ayurveda |
O.P.D-103 Hospital block, All India institute of Ayurveda
mathura road Gautampuri Sarita Vihar ,New Delhi-110076 South DELHI |
7291887810
drradhakumari2015@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
with signs and symptoms of allergic rhinitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Haridrakhanda orally,
pratimarsha nasya with Anutail nasal drops |
Haridrakhanda orally 6gmBD,
Anutail nasal drops, 2 drops per day in pratimarsha nasya in each nostril
|
Intervention |
Haridrakhanda orally,marsha nasya with Anutail |
Haridrakhanda orally 6gmBD, Anutail 8 nasal drops per day in marsha nasya in each nostril |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
39.00 Year(s) |
Gender |
Both |
Details |
with signs and symptoms of Vataja pratishyaya(Allergic Rhinitis)
patients is willing and able to participate in study
SFAR score less than <7; no allergic rhinitis and if SFAR score more than and equal to 7 ;allergic rhinitis |
|
ExclusionCriteria |
Details |
Fever, hypertrophic rhinitis, atrophic rhinitis, rhinitis sicca, patients suffering from systemic diseases like TB, DM, etc, pregnant and lactating mothers |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in the clinical features of Vataja Pratishyaya-(Allergic rhinitis) assessed
through the specific questionnaire and tools. |
patient will be assessed at the end of three month. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To enhance the quality of life. |
it will be evaluated after the end of the study. |
|
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 1 |
Date of First Enrollment (India)
|
30/03/2018 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
The outcomes of the study will be communicated to peer reviewed journals for wider dissemination |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Pratishyaya (Rhinitis) has been a major problem
to the physicians since long back.
Vataja Pratishyaya (Allergic rhinitis)
by word itself indicates that it is a recurrent condition and can precipitate
due to Minute etiological factors. Vata is the main dosha and Pitta, Kapha
are associated doshas.
Nose is the sense organ which perform two main functions
i.e. olfaction and respiration. Due to its direct contact with environment it
is exposed to lots of microorganism, allergens and pollutants present in
atmosphere. This disease is characterized by sneezing, running, stuffy and
itchy nose, coughing, sore-throat, watery eyes, and frequent headaches.
In Ayurveda the Shira (head) is called the root of the
body as it contains Prana and all Indriyas.
The Nasya
is the choice of administration of the medicine for the diseases manifesting at
Urdhwajatrugata region and nose is
the gate way of Head, that means drugs administered via nose is highly
effective in curing of diseases pertaining to head. It cleanses & opens the
channel of head and also has influence on the function of Brain. In classics ,
it has mentioned that daily administration of Anu Taila act as a preventive
and curative remedy for the diseases and preserves the health of the healthy
individual.
Many oral preparations have been mentioned in the Ayurvedic
texts for the treatment of Pratishyaya.
One amongest them is Haridrakhanda . Haridra is the main content of it and is having
antihistaminic, antibacterial, antifungal, Shothaghna,
Kandughna; Trikatu is having anti-inflammatory, antirhinoviral,
antibacterial, Rasayana etc.
properties, Triphala is having Srotoshodhana, Rasayana, antihistaminic,
anti-inflammatory, antibacterial etc. properties.
Vidanga is having
anti-inflammatory, antibacterial, Rasayana,
Srotoshodhaka etc. properties.
Haridrakhanda also
has the properties like Medhya, Rasayana,
Balya, Brimhana, Agni Deepana,
Pachana, Shothahara, Jwarahara etc. which promotes the physical and mental health
of the patient. |