| CTRI Number |
CTRI/2026/03/105563 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Khafaqan (Palpitation) with the Unani Medicine Jawarish-e-Tamar Hindi and Jawarish-e-Shahi |
|
Scientific Title of Study
|
Comparative Clinical Validation study of Unani Pharmacopoeial Formulation Jawarish-e-Tamar Hindi vs Jawarish-e-Shahi in Khafaqan (Palpitation) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| K/P/JT/JS/CLNVAL/CCRUM/23-24, Version-01, 25.11.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis I Munshi |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
DELHI
110058
India |
| Phone |
09419086700 |
| Fax |
|
| Email |
younismunshi@gmail.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 |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: 1.Regional Research Institute of Unani Medicine, Chennai. 2.Regional Research Institute of Unani Medicine, Patna. 3.Regional Research Centre, Prayagraj. |
| Monetary Support : Central Council for Research in Unani Medicine,Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| 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 Ashok Kumar |
Regional Research Centre, Prayagraj |
Research OPD Room Khafaqan (Palpitation), B-501/4, GTB Nagar,Opp. Dulhan Palace, Kareli, Prayagraj– 211016
Allahabad
UTTAR PRADESH |
9450619024
rrcallahabad@gmail.com |
| Dr Syed Sadakathullah Bhaktiari |
Regional Research Institute of Unani Medicine, Chennai |
Research OPD Room Khafaqan (Palpitation), 1, West Meda Church Street, Royapuram, Chennai – 600013
Chennai
TAMIL NADU |
8951345010
syednium@gmail.com |
| Dr Abdur Rasheed |
Regional Research Institute of Unani Medicine, Patna |
Research OPD Room Khafaqan (Palpitation),Guzri, Patna City, Patna– 800008
Patna
BIHAR |
7008500913
dr.rasheedrrium@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of RRC, Prayagraj |
Approved |
| Institutional Ethics Committee of RRIUM, Chennai |
Approved |
| Institutional Ethics Committee of RRIUM, Patna |
Approved |
|
|
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 |
| Comparator Agent |
Jawarish e- Shahi |
05 gm twice daily, to be taken with plain water after meals for a duration of 4 weeks. |
| Intervention |
Jawarish e-Tamar Hindi |
05 gm twice daily, to be taken with plain water after meals for a duration of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-65 years.
2. Patients experiencing palpitations who exhibit any of the following symptoms:
I. Chest discomfort.
II. Shortness of breath
III. Missed Heart Beat Sensation.
IV. Awareness of heart beating. |
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 65 years of age.
2. Patients with history of structural heart disease.
3. Patients with cardiac pacemakers or other implanted electronic devices.
4. Any gross abnormality detected on ECG.
5. Patient with History of severe hepatic, renal/ respiratory disorder, diabetes mellitus, hypertension, hyperthyroidism, anemia.
6. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the signs and symptoms of Khafaqan (palpitations). Which will be assessed on the basis of EQ 5D 5L questionnaire with EQ VAS. |
At baseline and subsequently at weekly intervals (i.e., Week 1, Week 2, Week 3, and Week 4) during the protocol therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT, KFT, Urine Examination: Routine & Microscopic |
At baseline, first Follow-up and at the end of the protocol therapy. i.e., 0, 1st & 4th week.
|
|
|
Target Sample Size
|
Total Sample Size="318"
Sample Size from India="318"
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 2 |
|
Date of First Enrollment (India)
|
14/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as
a multi-centric, Randomized, Parallel Group, Active Controlled
trial in patients with Khafaqaan (Palpitation). After
screening, Patients will be enrolled if they satisfy inclusion and exclusion
criteria. The
patients will be assessed clinically at baseline and
subsequently at weekly intervals (Week 1, Week 2, Week 3, and Week 4) during
the protocol therapy. The subjective and objective clinical observations will
be recorded in the follow-up sheet. 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 (i.e.,
0, 1st & 4th weeks).
Composition of Jawarish-e-Tamar
Hindi
|
S. No
|
Ingredients
|
Scientific
name
|
Quantity
|
|
1.
|
Gul-e-surkh
|
(Rosa
damascene Mill)
|
20g
|
|
2.
|
Kishneez
|
(Coriander sativum Linn)
|
20g
|
|
3.
|
Mastagi
|
(Pistacia lentiscus Linn)
|
10g
|
|
4.
|
Dana heel
khurd
|
(Elettaria cardamum)
|
10g
|
|
5.
|
Zarishk
|
(Berberis aristate)
|
10g
|
|
6.
|
Tabasheer
|
(Bambusa arundinaceae)
|
10g
|
|
7.
|
Sazij hindi
|
(Cinnamomum tamala)
|
10g
|
|
8.
|
Post turanj
|
(Citrus
medica)
|
10g
|
|
9.
|
Sandal
safaid
|
(Santalum album)
|
10g
|
|
10.
|
Aab anar
|
(Punica
granatum)
|
100ml
|
|
11.
|
Aab tamar
hindi
|
(Tamarindus indica)
|
150ml
|
|
12.
|
Muraba amla
|
(Embelica officinalis)
|
150g
|
|
13.
|
Qand safaid
|
(Saccharum
officinarum)
|
600g
|
National Formulary of Unani
medicine Part I, p.no 105 Composition of comparator: Jawarish Shahi
|
S. No
|
Ingredients
|
Scientific
name
|
Quantity
|
|
1.
|
Murabba-e-Halela
|
(Terminalia chebula Roxb.)
|
5 No.
|
|
2.
|
Murabba-e-Aamla
|
(Emblica officinalis Gaertn.)
|
4 No.
|
|
3.
|
Araq-e-Bed Mushk
|
(Salix
caprea L.)
|
Q.S.
|
|
4.
|
Kishneez
|
(Coriander sativum Linn)
|
12 g
|
|
5.
|
Heel khurd
|
(Elettaria cardamom Maton)
|
3 g
|
|
6.
|
Qand safaid
|
(Saccharum
officinarum)
|
2 times
of all ingredients
|
National Formulary of Unani
medicine Part I (revised) p.no 144-145
|