| CTRI Number |
CTRI/2018/10/015910 [Registered on: 05/10/2018] Trial Registered Prospectively |
| Last Modified On: |
12/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Non Ulcer dyspepsia with Unani medicine Majoon-e-Sangdana Murgh |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Majoon-e-Sangdana Murgh in Du‘f al-Mi‘da (Functional Dyspepsia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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 |
| 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 (Unani) |
| Affiliation |
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
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 (Path) SIV |
| Affiliation |
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
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), Srinagar 2. Regional Research Institute of Unani Medicine(RRIUM), Aligarh 3. Regional Research Institute of Unani Medicine (RRIUM), Bhadrak 4. Central Research Institute of Unani Medicine (CRIUM), Hyderabad Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM |
| Address |
Central Council for Research in Unani Medicine(CCRUM), 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Nawab |
Central Research Institute of Unani Medicine |
Research OPD Room (Functional Dyspepsia/Du‘f al-Mi‘da)
A G Colony Road, Erragadda
Hyderabad
ANDHRA PRADESH |
8100992044
ccrumnawab@gmail.com |
| Dr Athar Parvez Ansari |
Regional Research Institute of Unani Medicine |
Research OPD Room (Functional Dyspepsia/Du‘f al-Mi‘da)
Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR |
9952961233
atharparvez@gmail.com |
| Dr Shagufta Rehman |
Regional Research Institute of Unani Medicine |
Research OPD Room (Functional Dyspepsia/Du‘f al-Mi‘da)
Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
9456667107
drrehmanshagufta@gmail.com |
| Dr Syed Abdullah Hussaini |
Regional Research Institute of Unani Medicine |
Research OPD Room (Functional Dyspepsia/Du‘f al-Mi‘da)
Chandbali By-pass Road, Near Rural Police Station
Bhadrak
ORISSA |
9861142159
abuasad_65@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine Hyderabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine Aligarh |
Approved |
| Regional Research Institute of Unani Medicine Bhadrak |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine Srinagar |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, (2) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e-Sangdana |
5-10g Orally twice daily with plain water after meal for six 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 meeting the Rome III diagnostic criteria for PDS
|
|
| ExclusionCriteria |
| Details |
1 Presence of GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion.
2 Having overlap syndrome combined with gastro esophageal reflux disease or irritable bowel syndrome
3 Having alarm symptoms (weight loss, black or tar stool, dysphasia, etc.)
4 Having any systemic disease (diseases of heart, lung, liver or kidney) or mental illness
5 History of surgery related with the gastrointestinal tract more than six months ago
6 Taking drugs which may affect the gastro intestinal tract, such as non-steroidal anti-inflammatory drugs and aspirin
7 Known Allergy to the experimental medications
8 Pregnant and breastfeeding
9 Refusing to sign the informed consent
|
|
|
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 Du‘f al-Mi‘da (Functional Dyspepsia) |
Six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
08/10/2018 |
| 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 Du‘f al-Mi‘da (Functional Dyspepsia) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be Six weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition
of Majoon-e-Sangdana Murgh
|
S.
No.
|
Ingredients
|
Botanical
/ Scientific Name
|
Quantity
|
|
1.
|
Gul-e-Surkh
|
Rosa damascena Mill.
|
100
g
|
|
2.
|
Post-e-Sangdana Murgh
|
Gizzard of the Cock/ Hen
|
90
g
|
|
3.
|
Tabasheer
|
Bambusa arundinacea
|
90 g
|
|
4.
|
Behman Safaid
|
Centaurea behen Linn.
|
70 g
|
|
5.
|
Behman Surkh
|
Salvia haematodes Linn.
|
70 g
|
|
6.
|
Sandal Surkh
|
Pterocarpus
santalinus Linn.
|
70 g
|
|
7.
|
Sandal Safaid
|
Santalum album Linn.
|
70 g
|
|
8.
|
Saatar Farsi
|
Zataria multiflora Boiss.
|
70g
|
|
9.
|
Kishneez Khushk Biryan
|
Coriandrum sativum Linn.
|
70 g
|
|
10.
|
Habb-ul-Aas
|
Myrtus communis Linn.
|
70 g
|
|
11.
|
Pudina Khushk
|
Mentha
arvensis Linn.
|
45 g
|
|
12.
|
Post-e-Berun-e-Pista
|
Pistacia vera Linn.
|
45 g
|
|
13.
|
Post-e-Turanj
|
Citrus medica Linn.
|
45 g
|
|
14.
|
Post-e-Halela Zard
|
Terminalia chebula Retz.
|
45 g
|
|
15.
|
Qand Safaid
|
Sugar
|
3 kg
|
|