| CTRI Number |
CTRI/2017/03/008225 [Registered on: 27/03/2017] Trial Registered Prospectively |
| Last Modified On: |
15/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Dushta Pratishyaya w.s.r. to chronic sinusitis |
|
Scientific Title of Study
|
Comparative clinical study of Chitraka Haritaki Avaleha, Vyaghri Taila Nasya along with and without Saraladi Dhoompana in the management of Dushta Pratishyaya (Chronic Sinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amisha Patel |
| Designation |
Phd scholar |
| Affiliation |
IPGT and RA, GAU, Jamnagar |
| Address |
Shalakya Tantra Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Shalakya Tantra Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9723273584 |
| Fax |
|
| Email |
amisha.patel1311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D B Vaghela |
| Designation |
Associated Professor |
| Affiliation |
IPGT and RA, GAU, Jamnagar |
| Address |
Shalakya Tantra Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Shalakya Tantra Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D B Vaghela |
| Designation |
Associated Professor |
| Affiliation |
IPGT and RA, GAU, Jamnagar |
| Address |
Shalakya Tantra Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Shalakya Tantra Department
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduation Teaching And Research in Ayurveda |
| Address |
Institute for Post Graduation Teaching And Research in Ayurveda OPP. City B Police Station PN
Marg JAMNAGAR |
| 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 |
| Amisha Patel |
Institute for Post Graduate Teaching and Research in Ayurveda |
OPD No 3 Shalakya Tantra Department Institute for Post Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008
Jamnagar
GUJARAT |
9723273584
amisha.patel1311@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having nasal blockage, nasal discharge, heaviness in head i.e. Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
chitraka Haritaki Avaleha orally 5 gm twice a day along with 3 sitting of Nasya with Vyaghri Taila and Saraladi Dhhomapana after Nasya |
| Comparator Agent |
Group B |
Chitraka Haritaki Avaleha orally 5 gm twice a day with 3 sitting of Vyaghri Taila Nasya |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fulfilling the diagnostic criteria based on sign and symptoms of Dushta Pratishyaya (Chronic Sinusitis) in Ayurvedic classics and modern science will be selected for the present study.
2 Patients will be include into the study irrespective of caste, religion, sex etc. |
|
| ExclusionCriteria |
| Details |
1 Patients below 18 and above 60 years of age.
2 Chronic debilitating disease like diabetes mellitus CA AIDS.
3 Cases which require surgical treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| management of Chronic sinusitis |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Achieve normal ventilation of para-nasal sinuses |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="119" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/04/2017 |
| Date of Study Completion (India) |
28/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Chronic Sinusitis (CS) is a common disease
worldwide, particularly in places with high levels of atmospheric pollution. Its
estimated prevalence ranges widely, from 2 to 16%. People who are suffering
from CS have experience of significant decrease in quality of life and
productivity. In modern medical science, only symptomatic relief can be
provided by the treatment and recurrence rate is very high in spite of surgical
management. There are so many treatment modalities described in Ayurvedic
text for nasal disease such as Nasya, Dhoompana etc. Number of works were
carried out on Nasya proving its efficacy in CS. Dhoompana is one of the best
therapies for diseases of Supra clavicular region specially Vata Kapha predominancy.
Therefore, present study is designed to evaluate comparative efficacy of Dhoomapana
in management of Dushta Pratishyaya (Chronic Sinusitis). Total 119 patients registered, among them 102
patients have completed their course and 17 patients left the treatment due to
their personal reason. The selected patients were assigned randomly into two groups (i.e. A and
B), 63 patients were assigned in group A among them 51 was completed treatment and
56 patients were assigned in group B among them 51 was completed treatment. Patients of Group A were treated with Chitraka
Haritaki Avaleha orally (5gm BD with Luke warm water) and Vyaghri Taila Nasya
following
by Saraladi Dhoompana (3
sitting of 7 days with gap of 3 days). Patients of Group B were
treated with Chitraka Haritaki Avaleha orally (5gm BD with Luke warm
water) and Vyaghri Taila Nasya without Saraladi Dhoompana (3
sitting of 7 days with gap of 3 days). After completion of the treatment, the patients were
followed for one month at the interval of 15 days. Effect of therapy on subjective
parameters showed statistically highly significant (<0.001)
improvement in both groups but percentage wise better result was found in Group
A than Group B. Effect of therapy on objective parameters showed statistically
highly significant (p<0.001) improvement was obtained in paranasal sinuses
tenderness and nasal endoscopic findings in both groups. Percentage wise better
result was obtained in Group A than Group B. Effect of therapy on radiological
findings showed statistically significant result (p<0.05) in right maxillary
and right frontal sinus while statistically insignificant result (p>0.05)
was obtained in left maxillary and left frontal sinus in Group A While in Group
B statistically insignificant results were found in right-left Maxillary and
right Frontal sinus. Overall effect of therapy showed in Group A that 74.51%,
19.61% and 05.88% patients got marked, moderate and complete relief
respectively whereas in Group B 54.90%, 41.18% and 03.92% patients got
moderate, marked and mild relief respectively. None patients remain unchanged
in both groups. Thus, overall effect of therapy showed better result in Group A
than in Group B. It can
be inferred that Group A i.e. Chitraka Haritaki Avaleha orally and Vyaghri
Taila Nasya along with Dhoompana was showing better result than
Group B i.e. Chitraka Haritaki Avaleha orally and Vyaghri Taila Nasya
without Dhoompana in Dushta Pratishyaya. Survey study: A questionnaire type of
survey study which was observational study carried out to elicit possible etiological factors of the disease Dushta Pratishyaya (Chronic
Sinusitis) and a special survey questionnaire was
constructed for this. In survey study, cold atmosphere (79.83%), dusty
atmosphere (73.94%), history of long-standing nasal infection (77.31%), indigestion
(52.94%), Wet (humid) atmosphere (45.37%), habit of suppress natural urges (42.02
%) were observed as etiological factors. Microbiological study of Chitraka
Haritaki Avaleha to check the sterility of Avaleha was done. Sample
of Chitraka Haritaki Avaleha was analyzed monthly during clinical study period to
assess any microbial contamination at different climatic conditions and
temperature set ups. Till last date of study (i.e. drug completion time) no
contamination was found. Maximum temperature noted during study was 33º C
and minimum was 15º C whereas relative humidity was noted 93% (maximum) and 22%
(minimum). Thus, it is proved that drug preparation was done according to
standard operating procedure and stored at proper humidity and temperature in
air tight container at appropriate place; although having higher moisture content,
Avaleha does not get contaminated. |