To study the effect of Unani drug in the treatment of patients with Chronic obstructive pulmonary disease.

Phase 2/3

Completed

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2018/02/012180
• Lead Sponsor: Jamia Hamdard

Brief Summary

Thus in order to evaluate the effect of Lauq-e-Katan (*Linium usitatissimum L.*) in the management of COPD, the present study was designed to evaluate its effects on Spirometric Parameter in Chronic Obstructive Pulmonary Disease Patients. It was carried out in the Majeedia Hospital/HAHC Hospital, Jamia Hamdard. All the patients were enrolled in OPD clinic. The test group was given Lauq-e-Katan (*Linium usitatissimum L.*), a Unani pharmacopeia formulation 10 gms thrice a day. The study was randomized standard drug controlled trial. In this study, 80 patients were enrolled out of which 60 patients were included in the study. The patients were distributed randomly by the simple randomization using the RAND function in the Microsoft office excel into test and control group. During the study 13 patients lost to follow up and 47 patients completed the study. Out of 47 patients 25 patients were in the test group and 22 patients in the control group. All the patients in the test group were given the test drug for 6 weeks, followed up at every week. Similarly patients in control group were given standard theophylline 200mg thrice daily for 6 weeks, followed up at every week.

The two groups were closely matched for the demographic data and after the analysis of the data it was found that there was no statistical significant difference in the demographic pattern between the two groups at the start of the treatment, thus supporting randomization.

The assessment of efficacy was done on clinical parameters viz. MRC-D Scale for (Dyspnea), cough, sputum, wheeze along with need for supportive medication that was needed in between among both the test as well as control group. The MRC-D Scale was recorded at the baseline (0 day), mid (21st day) and last visit (42nd day), whereas cough, sputum and its colour, wheeze along with supportive medication (when needed) were recorded at the baseline (0 day) and after the treatment (42nd day).

For the evaluation of the safety and drug tolerance and drug efficacy, the hematological parameters, liver function test and kidney function test were carried out before, mid and at the end of the treatment. The statistical analysis of the data was done after the completion of the treatment and was observed that the test drug (Lauq-e-Katan) has no adverse effect on Blood Cells counts, Liver as well Kidney function tests.

The improvement in Dyspnea (p=0.009), cough (p=0.002), wheeze (p<0.001) was extremely significant in the test group, while there was a significant improvement in expectoration in control group (p=<0.001). In the test group there was no reduction in sputum expectoration throughout the treatment.

There was again, a statistically significant difference seen between the test and the control group was regard to use of supportive medication (p = <0.001) in addition to the treatment given. It was observed that most of the patients in the test group did not require supportive medication whereas; most of the patients required the supportive medicine during standard treatment.

The drug tolerance and the drug efficacy as reported by the patients and observed during the study, was much better tolerated in case of test group as compared to the control group. While doing the statistical evaluation it was observed that both the parameters were highly significant in the test group when compared with control group (p<0.001 and <0.001 respectively).

The spirometric parameters (FVC; FEV1; FEV1/FVC) were recorded in both the groups before treatment and at the end of the treatment. While recording the spirometric parameters in both the test and the control group it was observed that there was statically significant difference in FVC, FEV1 & FEV1/FVC in both test as well as control group after the treatment. This signifies that both the test and control drug have significant effect on spirometric parameters. Control drug (Theophylline) is a second-line standard pharmacopeial drug recommended in COPD (GOLD Updated 2010; Wen-Hui Zhang et al-2011; Alfred P. Fishman et al-2008; Hansel T.T et al-2004). Whereas, the test drug (Lauq-e-Katan) is a Unani pharmacopeial formulation recommended for Usr-e-Tanaffus/Zeeq-un-Nafas (COPD) (Rafiqueddin M-1985; Kabeeruddin M-1995; Jilani G; Said M-1997; NFUM-2006; CCRUM-1987; Zillurrehman S-1991; Hussain-1995). Based on the observations of this study, it may be concluded from this study that the test drug (Lauq-e-Katan) has a significant effect on Spirometry and accordingly could justify the effective treatment for COPD. Observations also are suggestive that on the given parameters Lauq-e-Katan could be taken at par with Theophylline in its effectiveness in COPD.

Through all these observations, it could be concluded that test formulation (Lauq-e-Katan) is considerably safe and well tolerated in comparison to control drug (Theophylline). It is highly effective to reduce the signs and symptoms (Dyspnea, Cough, and Wheeze etc) along with significant effect on the spirometric parameters.

It may be therefore concluded from the clinical study entitled“A Clinical Study on the Effects of Lauq-e-Katan (Linum usitatissimum) on Spirometric Parameter in Chronic Obstructive Pulmonary Disease Patients†that Lauq-e-Katan is a considerably promising drug in the treatment of mild to moderate Chronic Obstructive Pulmonary Disease patients (COPD).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-27
• Study Completion: 2014-03-02
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Known Moderate cases of COPD based on Gold Criteria defined by WHO.
• Patients who are willing to participate.

Exclusion Criteria

• Patients aged less than 18 years Patients having acute exacerbation of breathlessness Patients having severe or very severe COPD.
• patients taking β-blockers/ACE inhibitors Patients suffering from Diabetes Mellitus, Hepatic Failure, Renal Failure, Congestive Heart Failure.
• Pregnant and lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Spirometric Parameters (FEV1, FEV1/FVC )	after 6 wks of the treatment

Secondary Outcome Measures

Name	Time	Method
Improvement in MRC-D Scale	after 6 wks of the treatment

Trial Locations

Locations (1)

Majeedia Unani Hospital; 🇮🇳 Delhi, DELHI, India

Majeedia Unani Hospital

🇮🇳Delhi, DELHI, India

Azhar Jabeen

Principal investigator

9899315252

jabeendr@gmail.com