To evaluate the Safety and efficacy of Unani formulation in the treatment of Palpitation

Phase 2

Recruiting

• Conditions: Palpitations,

• Registration Number: CTRI/2015/02/005525
• Lead Sponsor: Central Council for Research in Unani MedicineCCRUM

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 assessed clinically everyweek.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. . Laboratory parameters for safety assessment will be conducted at baseline, first follow up and on completion of the protocol therapy.

**Composition**

***Dawa-ul-Misk MutadilSada***

**Nameof ingredients  Botanical/Zoological Name   Quantity**

1.Zarishk                    (*Berberis vulgaris*)                  50gm              2. Tabasheer                (*Bambusa bambos*)                 30 gm              3. Sandal Safaid          (*Santalum album*)                    30 gm

4.Sandal Surkh           (*Pterocarpus santalum*)           30 gm

5.Kishneez Khusk Muqashar (*Coriandrum sativum*) 30 gm  6. Gul-e-Gaozaban      (*Borago officinalis*)                 30gm

7.Aamla                      (*Phylanthus emblica*)              30 gm

8.Tukhm-e-Khurfa     (*Portulaca oleracea*)               30gm

9.Gul-e-Surkh                        (*Rosa damascena*)                   20 gm

10.Abresham              (*Bombax mori*)                        20 gm

11.Darchini                (*Cinnamomum zeylanicum*)    20 gm

12.Bahaman Safaid    (*Centaurea behen*)                  20gm

13.Bahman Surkh      (*Saviahaematodes*)                 20 gm

14.Darunaj Aqrabi     (*Doronicum hookrii*)               20 gm

15.Ood Hindi             (*Aquilaria agallocha*)              15 gm

16.Badranjboya          (*Melissa parviflora*)                 15 gm

17.Mastagi                 (*Pistacia lentiscus*)                  10 gm

18.Ushna                    (*Usnea longissima*)                 10 gm

19.Dana Heel Khurd (*Elettaria cardamomum*)         10 gm

20.Zafran                   (*Crocus sativus*)                      10 gm

21.Mushk                   (*Moschcus moschiferus*)          10 gm

22.Ambar Ashhab      (*Ambra grasea*)                       5gm

23.Aab-e-Seb Sheerin (*Malus domestica*)                  450 ml

24.Asl                         (*Apis mellifera*)                        450 gm

25.Qand Safaid          (*[Saccharum officinarum](http://en.wikipedia.org/wiki/Saccharum_officinarum "Saccharum officinarum")*)        900 gm

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-05
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

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 Feeling of Missed Beat Discomfort in Chest Sweating Dizziness.

Exclusion Criteria

• •History of any heart diseases •History of hepatic, renal disorders, diabetes mellitus, hypertension, anaemia, COPD •History of thyroid dysfunction •History of hypersensitivity to any ingredient of the study drug.
• •Participants with history of long term use of any other drugs such as anti-epileptic, anti-arrhythmic and anti-psychotic drugs etc.
• •History of Addiction (smoking, alcohol, drugs) •Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms	4 weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	4 weeks

Trial Locations

Locations (4)

Central Research Institute of Unani Medicine (CRIUM), Hyderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Clinical Research Unit (CRU), Bhurhanpur; 🇮🇳 Nimar, MADHYA PRADESH, India

Regional Research Centre (RRC), Allahabad; 🇮🇳 Allahabad, UTTAR PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM), Aligarh; 🇮🇳 Aligarh, UTTAR PRADESH, India

Central Research Institute of Unani Medicine (CRIUM), Hyderabad

🇮🇳Hyderabad, ANDHRA PRADESH, India

DR MUSHEER AHMAD KHAN

Principal investigator

04023810246

criumhyderabad@gmail.com