Irfan Ahmed1 , Nikhat Shaikh1 , MD Manzar Alam2 , Shah Alam1 , Arjumand Shah3 , Mohammed Sheeraz4 , Nighat Anjum5
1Regional Research Institute of Unani Medicine (RRIUM), Mumbai, Maharashtra, India
2Regional Research Institute of Unani Medicine (RRIUM), Patna, Bihar, India
3Regional Research Institute of Unani Medicine, Naseem Bagh, Habbak, Srinagar, 190006 Jammu & Kashmir, India
4Department of Moalajat, Regional Research Institute of Unani Medicine, Srinagar, Jammu & Kashmir, India
5Central Council for Research in Unani Medicine (CCRUM), New Delhi, India
Corresponding Author Email: drnikhat.unani@gmail.com
DOI : https://doi.org/10.51470/APR.2022.01.02.01
Abstract
Background: Sual-e-Yabis (dry cough) is a common respiratory ailment described in classical Unani texts as a condition primarily of Yabusiyat (dryness) affecting the respiratory tract. Sharbat-e-Ejaz is a compound Unani formulation included in the Unani Pharmacopoeia of India (UPI) with documented anti-tussive and mucolytic properties. Objective: To clinically validate the efficacy and safety of Sharbat-e-Ejaz in patients with Sual-e-Yabis through a multi-centre open-label clinical trial. Methods: A total of 128 patients (Male: 88, Female: 40) with confirmed diagnosis of Sual-e-Yabis were enrolled from four CCRUM research institutes. The formulation was administered orally for four weeks with assessments at baseline, 2nd week (1st follow-up) and 4th week (end of treatment). Primary outcome was assessed using the Visual Analogue Scale (VAS). Laboratory investigations including haematological and biochemical parameters were performed to assess safety. Results: Mean VAS score significantly decreased from 7.91 ± 1.35 at baseline to 2.69 ± 1.18 at end of treatment, reflecting a 65.9% reduction (p < 0.001). No clinically significant adverse changes were observed in laboratory parameters. Conclusion: Sharbat-e-Ejaz demonstrated significant clinical efficacy and acceptable safety profile in the management of Sual-e-Yabis, supporting its validation as a standard Unani therapeutic formulation.
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Introduction
Sual-e-Yabis, described in classical Unani literature as dry cough, represents one of the most prevalent respiratory conditions encountered in clinical practice. Unlike Sual-e-Ratab (productive cough), Sual-e-Yabis is characterised by absence of expectoration, persistent irritation of the respiratory mucosa, and predominance of Yabusiyat (dryness) in the Mizaj (temperament) of the affected organ.[1] In Unani medicine, cough (Sual) is understood as a reflex expulsive action of the lung aimed at expelling harmful materials or relieving irritation in the respiratory tract. Classical scholars such as Ibn Sina in his canonical text Al-Qanoon fi al-Tibb have classified Sual based on its aetiology, intensity and the nature of expectorated material. Sual-e-Yabis specifically arises due to accumulation of Khilt-e-Sawda (melancholic humour) or extreme Yabusiyat affecting the respiratory mucous membranes, leading to persistent dryness and tickling sensation [2][3]. The global burden of dry cough is substantial. Studies indicate that chronic or acute dry cough affects approximately 10-40% of the population at any given time, with significant impact on quality of life, sleep and social functioning.[4] In India, respiratory conditions including cough-variant presentations account for a significant proportion of outpatient consultations in both modern and traditional medicine settings [5]. Sharbat-e-Ejaz is a classical Unani compound syrup formulation included in the Unani Pharmacopoeia of India (UPI), Part-II. Its primary ingredients include drugs with established demulcent, anti-tussive and soothing properties such as Unnab (Ziziphus jujuba), Sapistan (Cordia myxa), and Khatmi (Althaea officinalis). These ingredients possess established pharmacological actions including mucilaginous, anti-inflammatory, and antioxidant properties [6][7].
The Central Council for Research in Unani Medicine (CCRUM), Ministry of AYUSH, Government of India, has undertaken systematic clinical validation of pharmacopoeial Unani formulations through multi-centre clinical trials. The present study was conducted under Protocol No. SY/DC/SE CLNVAL/CCRUM 13-14 at four CCRUM research institutes: RRIUM-Srinagar, RRIUM-Mumbai, RRIUM-New Delhi, and CRU-Meerut. The objective was to validate the clinical efficacy and safety of Sharbat-e-Ejaz in patients diagnosed with Sual-e-Yabis, thereby generating scientific evidence for its therapeutic use [8].
2. Materials and Methods
2.1 Study Design
This was a multi-centre, open-label, single-arm clinical trial conducted at four CCRUM research institutes across India. The study followed the guidelines of the Indian Council of Medical Research (ICMR) for biomedical research on human participants and received ethical approval from respective Institutional Ethics Committees.
2.2 Study Population
Patients presenting with symptoms of Sual-e-Yabis (dry cough) to the outpatient departments of the participating centres were screened for eligibility. A total of 128 patients aged between 18 and 62 years (mean: 35.6 ± 10.1 years) were enrolled. Informed written consent was obtained from all participants prior to enrolment. Patients with severe underlying pulmonary pathology, pregnancy, or concurrent use of allopathic antitussive medications were excluded.
2.3 Diagnosis Criteria
Diagnosis of Sual-e-Yabis was established based on classical Unani diagnostic criteria including absence of expectoration, dry and harsh cough, tickling sensation in throat, signs of Yabusiyat in Mizaj assessment, and corroborated by conventional clinical examination. Nabz (pulse) examination and Mizaj assessment were performed at each visit.
2.4 Intervention
Sharbat-e-Ejaz was administered at the standard pharmacopoeial dose of 25 mL orally, twice daily (morning and evening), with water for a period of four weeks. The drug was procured from CCRUM-approved pharmaceutical units and quality tested as per UPI standards.
2.5 Outcome Assessment
The primary outcome measure was symptom severity assessed by Visual Analogue Scale (VAS) on a scale of 0–10, where 0 indicated no cough and 10 represented the most severe cough. Assessments were performed at three timepoints: Baseline (Week 0), 1st Follow-up (Week 2), and 2nd Follow-up/End of Treatment (Week 4). Safety was monitored through haematological parameters (Hb, TLC, DLC, ESR) and biochemical investigations (LFT, KFT, blood sugar) at baseline and end of treatment.
2.6 Statistical Analysis
Data were analysed using descriptive statistics (mean ± standard deviation). The significance of change in VAS scores was assessed using paired Student’s t-test and Wilcoxon signed-rank test. A p-value of < 0.05 was considered statistically significant. SPSS v20.0 (IBM, USA) was used for statistical analysis.
3. Results
3.1 Demographic Profile
Of the 128 patients enrolled (147 registered; 19 excluded/dropped-out prior to first assessment), 88 were male (68.8%) and 40 were female (31.2%). The mean age was 35.6 ± 10.1 years (range: 18–62 years). The majority of patients belonged to middle socio-economic status (74.2%). The mean disease duration was approximately 10 days. Demographic distribution is illustrated in Figure 2.
3.2 Effect on VAS Score
The mean VAS score at baseline was 7.91 ± 1.35, which declined to 5.10 ± 1.37 at the 1st follow-up (Week 2), and further reduced to 2.69 ± 1.18 at the end of treatment (Week 4). This corresponds to a total reduction of 65.9% in symptom severity from baseline to end of treatment. The improvement was statistically highly significant (paired t-test: t = 21.35, p < 0.001; Wilcoxon test: p < 0.001). The progressive reduction in VAS scores across all timepoints is shown in Figure 1.
Participants
3.5 Safety Parameters
Haematological and biochemical parameters showed no clinically significant changes following four weeks of treatment. Mean haemoglobin levels remained stable (baseline: 13.69 ± 1.72 g/dL; end of treatment: 13.67 ± 1.58 g/dL). ESR values were within acceptable ranges at both timepoints (baseline: 19.25 ± 12.34 mm/hr; end of treatment: 19.87 ± 12.33 mm/hr). No serious adverse events were reported during the trial period, confirming the safety profile of the formulation.
4. Discussion
The present multi-centre clinical trial provides robust evidence for the therapeutic efficacy of Sharbat-e-Ejaz in Sual-e-Yabis. The highly significant reduction in VAS scores (65.9%; p < 0.001) across the four-week treatment period indicates a consistent and progressive anti-tussive effect of this compound Unani formulation. These findings are concordant with the classical Unani understanding of the formulation’s mechanism — primarily through its Muqawwi and Mulayyin (soothing and moistening) actions on the respiratory mucosa [9]. The predominance of male patients (68.8%) in our cohort may reflect greater occupational exposure to environmental irritants, dust and pollutants, which are known precipitants of Sual-e-Yabis [10]. The mean age of 35.6 years indicates that working-age adults are the most vulnerable demographic, consistent with patterns reported in other studies on cough disorders in South Asian populations [11]. The ingredient profile of Sharbat-e-Ejaz offers pharmacological plausibility for the observed outcomes. Cordia myxa (Sapistan) has documented mucoprotective and anti-inflammatory properties, while Althaea officinalis (Khatmi) contains mucilaginous polysaccharides that coat and soothe inflamed mucous membranes [12][13]. Modern phytochemical research supports these mechanisms, providing scientific basis for the classical Unani pharmacological claims regarding this formulation. The stable laboratory parameters across the treatment period confirm the safety and tolerability of Sharbat-e-Ejaz, which is particularly relevant given its use in diverse patient populations including varying age groups and socio-economic backgrounds. The absence of hepatotoxic or nephrotoxic effects strengthens confidence in its long-term administration safety, aligning with findings from similar validation studies on compound Unani formulations [14].
5. Conclusion
Sharbat-e-Ejaz demonstrated statistically significant (p < 0.001) and clinically meaningful reduction in dry cough severity (65.9% VAS reduction) over four weeks of treatment in patients with Sual-e-Yabis. The formulation exhibited an excellent safety profile with no adverse effects on haematological or biochemical parameters. These findings provide scientific validation of this Unani Pharmacopoeial formulation, supporting its inclusion as a standard therapeutic option for Sual-e-Yabis in evidence-based Unani clinical practice. Larger randomised controlled trials with a comparator arm are recommended to further substantiate these findings.
Acknowledgment
The authors sincerely acknowledge Director General, Central Council for Research in Unani Medicine (CCRUM), Ministry of Ayush, Government of India, for his constant support and for providing the financial assistance and necessary facilities to carry out this validation study. His guidance and encouragement have been invaluable in enabling us to complete this work and publish it in a peer-reviewed journal.
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