Treatment of Palpitation (awareness of own heartbeat) by Unani medicine Khamira Abresham Sheera Unnab Wala

Phase 3

Not yet recruiting

• Conditions: Palpitations,

• Registration Number: CTRI/2020/02/023476
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

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 Wala***5gm 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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-17
• Study Start: 2020-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients of either sex in the age group of 18-60 2.
• 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 2.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Khafaqan (Palpitation)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	Investigations will be done at baseline and end of treatment

Trial Locations

Locations (2)

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

Regional Research Institute of Unani Medicine (RRIUM); 🇮🇳 Delhi, DELHI, India

Regional Research Institute of Unani medicine (RRIUM)

🇮🇳Bhadrak, ORISSA, India

Dr Anwar Jamal

Principal investigator

08447973003

anwarj74@gmail.com