MedPath

Treatment of throat infection with Unani medicine Habb-e-Khardal

Phase 3
Not yet recruiting
Conditions
Chronic pharyngitis,
Registration Number
CTRI/2024/07/071434
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

This study is designed as a multi centric open trial in patients with **Warm-e-Halaq (Pharyngitis)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 14days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

The treatment of *waram-e-halaq*has been described in Unani system of medicine. There are so many *Mufrad*(single) as well as *Murakkab* (Compound) Unani formulations mentioned inclassical texts which have been used in the treatment of *waram-e-halaq*by eminent Unani Physicians since ages and are known for theirefficacy and safety, but they need to be validated on scientific parameters inorder to generate data regarding their safety and efficacy.

*Habb-e-khardal* is an UnaniPharmacopoeial Formulation widely used by Unani physicians to relieve symptomsof*waram-e-halaq*(Pharyngitis).Therefore, the present clinical study has been planned to scientificallyvalidate the efficacy and safety of *Habb-e-khardal* in the treatment ofespecially in *waram-e-halaq*(Pharyngitis).



**Composition of *HABB -E -KHARDAL***

| | | | | |

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

|**S. No.**

**Ingredients**

**Scientific Name**

**Quantity**

**Ratio proportion**

|1.

*Filfil Siyah*

*Piper nigrum* Linn

10g

1

|2.

*Khardal biryan*

*Brassica nigra*

10g

1

|3.

*Kundur*

*Boswellia**serrata* Roxb

60g

6

|4.

*Mur Makki*

*Commiphora myrrha* Engl.

 60g

6

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
300
Inclusion Criteria
  • Patients of either sex in the age group of 18-60 years.
  • Patients having Sore throat Pharyngeal Inflammation along with any of these Cough Rhinorrhoea Hoarseness Oral ulcers Conjunctivitis.
Exclusion Criteria
  • Age below 18 and more than 60.
  • Patient with GERD.
  • Patient having bacterial pharyngitis.
  • Fever more than 100 F 5.
  • Weak debilitating patients 6.
  • Known cases of other clinically significant co-morbid conditions (severe hepatitis, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
  • Patients with laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator 8.
  • Known hypersensitivity to study drug or any of its ingredients.
  • Pregnancy and lactation 10.
  • Any Malignancy 11.
  • History of alcohol and drug abuse.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The efficacy of the study drug will be assessed on the basis Sore throat questionnaireAt baseline, 14th day and 21 day of treatment.
Secondary Outcome Measures
NameTimeMethod
Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.At baseline and after 14days

Trial Locations

Locations (2)

Clinical Research Unit

🇮🇳

Kannur, KERALA, India

Regional Institute of Unani Medicine

🇮🇳

Delhi, DELHI, India

Clinical Research Unit
🇮🇳Kannur, KERALA, India
Dr MAWAHEED
Principal investigator
7356589599
mawaheed313@gmail.com

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