Clinical Validation of Unani Pharmacopoeial Formulation Khamira Abresham Sheera Unnab Wala in Khafaqan (Palpitation)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Improvement in signs and symptoms of Khafaqan (Palpitation)
Study Overview
Brief Summary
This study is designed as a multicentric open trial in patients with Khafaqan (Palpitation)****. After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Khamira Abresham Sheera Unnab Wala5gm twice daily with water for four weeks. The patients will be assessed at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be four weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of****Khamira Abresham Sheera Unnab Wala
|Sl. No.
Ingredients
Botanical /Scientific Name
Quantity
| --- | --- | --- | --- | |1.
Abresham
Bombux mori
800 gm
|2.
Burada Sandal Safaid
Santalum album (Dust )
500 gm
|3.
Berg-e-Gaozaban
Borago officinalis
100 gm
|4.
Unnab
Zizyphus Vulgaris
550 gm
|5.
Rub Anar Tursh
Dry Extract of Sour Punica granatum
150 gm
|6.
Rub Anar Shirin
Dry Extract of Sweet Punica granatum
150 gm
|7.
Rub Angoor Shirin
Dry Extract of Sweet Vitis Vinifera
150 gm
|8.
Rub-e-Behi
Dry Extract of Cydonia vulgaris
150 gm
|9.
Rub Seb
Dry Extract of Malus pumila
300 gm
|10.
Zafran
Crocus sativus
5.2 gm
|11.
Ambar Ashhab
Ambra grasea
3 gm
|12.
Natroon Banjawi
Barilla
3 gm
|13.
Sat Leemun
Distillate of Citrus limon
12 gm
|14.
Shakar Safaid
Sugar
3.2 Kg
|15.
Arq Kewra
Aqueous Distillate of Pandanus odoratissiumus L.
75 ml
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex in the age group of 18-60
- •Patients of Palpitation (heart rate: < 60 or >100 bpm) with and without any of the following symptoms/ signs: Ghabrahat Discomfort in Chest Dizziness Breathlessness.
Exclusion Criteria
- •History of any heart diseases
- •History of hepatic, renal disorders, diabetes mellitus, hypertension, anaemia, COPD 3.History of thyroid dysfunction 4.History of hypersensitivity to any ingredient of the study drug.
- •5.Participants with history of long term use of any other drugs such as anti-epileptic, anti-arrhythmic and anti-psychotic drugs etc.
- •6.History of Addiction (smoking, alcohol, drugs) 7.Pregnant and lactating women.
Outcomes
Primary Outcomes
Improvement in signs and symptoms of Khafaqan (Palpitation)
Time Frame: 4 weeks
Secondary Outcomes
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)