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Clinical Trials/CTRI/2017/03/008225
CTRI/2017/03/008225CompletedPhase 2

Comparative clinical study of Chitraka Haritaki Avaleha, Vyaghri Taila Nasya along with and without Saraladi Dhoompana in the management of Dushta Pratishyaya (Chronic Sinusitis)

Institute for Post Graduation Teaching And Research in Ayurveda1 site in 1 country100 target enrollmentStarted: March 4, 2017Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
management of Chronic sinusitis

Study Overview

Brief Summary

Chronic Sinusitis (CS) is a common diseaseworldwide, particularly in places with high levels of atmospheric pollution. Itsestimated prevalence ranges widely, from 2 to 16%. People who are sufferingfrom CS have experience of significant decrease in quality of life andproductivity. In modern medical science, only symptomatic relief can beprovided by the treatment and recurrence rate is very high in spite of surgicalmanagement. There are so many treatment modalities described in Ayurvedictext for nasal disease such as Nasya, Dhoompana etc. Number of works werecarried out on Nasya proving its efficacy in CS. Dhoompana is one of the besttherapies for diseases of Supra clavicular region specially Vata Kapha predominancy.Therefore, present study is designed to evaluate comparative efficacy of Dhoomapanain management of Dushta Pratishyaya (Chronic Sinusitis). Total 119 patients registered, among them 102patients have completed their course and 17 patients left the treatment due totheir personal reason. The selected patients were assigned randomly into two groups (i.e. A andB), 63 patients were assigned in group A among them 51 was completed treatment and56 patients were assigned in group B among them 51 was completed treatment. Patients of Group A were treated with ChitrakaHaritaki Avaleha orally (5gm BD with Luke warm water) and Vyaghri Taila Nasyafollowingby Saraladi Dhoompana(3sitting of 7 days with gap of 3 days). Patients of Group B weretreated with Chitraka Haritaki Avaleha orally (5gm BD with Luke warmwater) and Vyaghri Taila Nasya without Saraladi Dhoompana (3sitting of 7 days with gap of 3 days). After completion of the treatment, the patients werefollowed for one month at the interval of 15 days. Effect of therapy on subjectiveparametersshowedstatistically highly significant (<0.001)improvement in both groups but percentage wise better result was found in GroupA than Group B. Effect of therapy on objective parameters showed statisticallyhighly significant (p<0.001) improvement was obtained in paranasal sinusestenderness and nasal endoscopic findings in both groups. Percentage wise betterresult was obtained in Group A than Group B. Effect of therapy on radiologicalfindings showed statistically significant result (p<0.05) in right maxillaryand right frontal sinus while statistically insignificant result (p>0.05)was obtained in left maxillary and left frontal sinus in Group A While in GroupB statistically insignificant results were found in right-left Maxillary andright Frontal sinus. Overall effect of therapy showed in Group A that 74.51%,19.61% and 05.88% patients got marked, moderate and complete reliefrespectively whereas in Group B 54.90%, 41.18% and 03.92% patients gotmoderate, marked and mild relief respectively. None patients remain unchangedin both groups. Thus, overall effect of therapy showed better result in Group Athan in Group B. It canbe inferred that Group A i.e. Chitraka Haritaki Avaleha orally and VyaghriTaila Nasya along with Dhoompana was showing better result thanGroup B i.e. Chitraka Haritaki Avaleha orally and Vyaghri Taila Nasyawithout Dhoompana in Dushta Pratishyaya. Survey study: A questionnaire type ofsurvey study which was observational study carried out to elicit possible etiological factors of the disease Dushta Pratishyaya (ChronicSinusitis) and a special survey questionnaire wasconstructed for this. In survey study, cold atmosphere (79.83%), dustyatmosphere (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 ChitrakaHaritaki Avaleha to check the sterility of Avaleha was done. Sampleof Chitraka Haritaki Avaleha was analyzed monthly during clinical study period toassess any microbial contamination at different climatic conditions andtemperature set ups. Till last date of study (i.e. drug completion time) nocontamination was found. Maximum temperature noted during study was 33º Cand minimum was 15º C whereas relative humidity was noted 93% (maximum) and 22%(minimum). Thus, it is proved that drug preparation was done according tostandard operating procedure and stored at proper humidity and temperature inair tight container at appropriate place; although having higher moisture content,Avaleha does not get contaminated.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

management of Chronic sinusitis

Time Frame: 1 month

Secondary Outcomes

  • Achieve normal ventilation of para-nasal sinuses(1 month)

Investigators

Sponsor
Institute for Post Graduation Teaching And Research in Ayurveda
Sponsor Class
Research institution and hospital

Study Sites (1)

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