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Clinical Trials/CTRI/2020/02/023476
CTRI/2020/02/023476Not yet recruitingPhase 3

Clinical Validation of Unani Pharmacopoeial Formulation Khamira Abresham Sheera Unnab Wala in Khafaqan (Palpitation)

Central Council for Research in Unani Medicine CCRUM New Delhi2 sites in 1 country300 target enrollmentStarted: February 28, 2020Last updated:

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)

Investigators

Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Sponsor Class
Research institution

Study Sites (2)

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