| CTRI Number |
CTRI/2020/02/023476 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Palpitation (awareness of own heartbeat) by Unani medicine Khamira Abresham Sheera Unnab Wala |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Khamira Abresham Sheera Unnab Wala in Khafaqan (Palpitation) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| K/P/KASUW/CLNVAL/CCRUM/18-19, Version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Bhadrak 2. Regional Research Institute of Unani Medicine (RRIUM), New Delhi 3. Regional Research Institute of Unani Medicine (RRIUM), Mumbai Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anwar Jamal |
Regional Research Institute of Unani medicine (RRIUM) |
Research OPD Room, Palpitation, Chandbali By-Pass Road
Bhadrak
ORISSA |
08447973003
anwarj74@gmail.com |
| Dr Masroor Ali Qureshi |
Regional Research Institute of Unani Medicine (RRIUM) |
Behind Eye Bank, Sir J J Hospital Compound, Research OPD Room Palpitation, Byculla
Mumbai
MAHARASHTRA |
9004040670
doctormasroorali@gmail.com |
| Dr S A H Zaidi |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Palpitation, D-11, Abul Fazal Enclave,Jamia Nagar
New Delhi
DELHI |
9312039212
drsahzadi786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine (RRIUM), Bhadrak |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), New Delhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R002||Palpitations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khamira Abresham Sheera Unnab Wala |
5gm twice daily to be taken orally with water after meals for four weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 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
|
|
| ExclusionCriteria |
| Details |
1. 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Khafaqan (Palpitation) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 | |