To study the medicinal effectiveness of Unani formulation “Sharbat Toot Siyah†in cases of Waram-i-Halaq (Pharyngitis)

Phase 2

Recruiting

• Conditions: Acute pharyngitis, unspecified, Waram-i-Halaq (Pharyngitis),

• Registration Number: CTRI/2015/10/006296
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

This study is designed as a multicentric open trial in patients with **Waram-i-Halaq (Pharyngitis)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessedclinically on Baseline, 3rd and 7th day of treatment.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of *Sharbat Toot Siyah***

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Unani Name**

**Scientific Name**

**Weight**

|1.

Aab-e-Toot Siyah

*Morusnigra* Linn.

1litre

|2.

Qand Safaid

Honey or sugar

1.5kg

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-04
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• 1.Patients of either sex in the age group of 18-60 years.
• 2.Presence of all of the following signs and symptoms of Waram-i-Halaq (Pharyngitis): 1.Buhha al-Sawt (Hoarseness of Voice) 2.Surfa Yubsiyya (Dry Cough) 3.‘Usr al-Bal (Dysphagia) 4.HumÄma Bul’ūm (Pharyngeal Erythema 5.Waja–e-halaq (Pain in throat).
• 6.Khushuna al-Halaq (Irritation in throat).

Exclusion Criteria

1.Patients with all four classic symptoms of Group A Streptococcal pharyngitis: •Pharyngeal or Tonsillar exudates •Swollen anterior cervical nodes •History of fever more than 380 C •Absence of cough 2.Known cases of Renal/ Hepatic/ Cardiac ailments/ Diabetes mellitus 3.Pregnant and lactating women 4.Oral candidiasis 5.Epiglottitis, 6.Herpes Simplex 7.Mononucleosis 8.Gastro esophageal reflux.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Waram-i-Halaq (Pharyngitis)	1 WEEK

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	1 WEEK

Trial Locations

Locations (4)

Regional Research Institute of Unani Medicine (RRIUM), Bhadrak; 🇮🇳 Bhadrak, ORISSA, India

Regional Research Institute of Unani Medicine (RRIUM), Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Regional Research Institute of Unani Medicine (RRIUM), Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Regional Research Institute of Unani Medicine (RRIUM), Patna; 🇮🇳 Patna, BIHAR, India

Regional Research Institute of Unani Medicine (RRIUM), Bhadrak

🇮🇳Bhadrak, ORISSA, India

Dr Shoab Ahmad Khan

Principal investigator

07205584347

drshoaibkhanbumsk@gmail.com