| CTRI Number |
CTRI/2018/08/015400 [Registered on: 21/08/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Unani Medicine Safoof-e-Teen in Zaheer (Dysentery) |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Safoof e Teen in Zaheer (Dysentery) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Z/D/ST/CLNVAL/CCRUM 16-17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| 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 |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| 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 |
|
| 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 (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 |
|
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine Bhadrak 2. Regional Research Centre Allahabad 3 Clinical Research Unit Kurnool Monetary Support: Central Council For Research In Unani Medicine |
|
|
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 South West DELHI 110058 India |
| 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 M Ramesh |
Clinical Research Unit |
Research OPD Room Safoof-e-Teen in Zaheer (Dysentery)
Doctor Abdul Haq Unani Hospital 40/23, Park Road
Kurnool
ANDHRA PRADESH |
9642479619
dr_ramesh4u@yahoo.co.in |
| Dr Zubair Ahmed Khan |
Regional Research Centre |
Research OPD Room Safoof-e-Teen in Zaheer (Dysentery)
B-501/4, G T B Nagar (Opposite Dulhan Palace)
Allahabad
UTTAR PRADESH |
05322551808
rrcallahabad@gmail.com |
| Dr Abdur Rasheed |
Regional Research Institute of Unani Medicine |
Research OPD Room Safoof-e-Teen in Zaheer (Dysentery)
Chandbali By Pass Road, Near Rural Police Station
Bhadrak
ORISSA |
8895543162
rasheed4984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Research Unit Kurnool |
Approved |
| Regional Research Centre Allahabad |
Approved |
| Regional Research Institute of Unani Medicine Bhadrak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A060||Acute amebic dysentery, (2) ICD-10 Condition: A069||Amebiasis, unspecified, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Safoof-e-Teen |
7gm twice daily orally To be taken with water after meals for six 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 18-65 years.
2. Patients of Zahīr (Dysentery) having the following signs and symptoms:
(i) 2-8 small-volume, semiformed or unformed stools/day
(ii) BarÄz DamwÄ« (Bloody Stools) and/or BarÄz MukhÄtÄ« (Mucoid Stools)
(iii) E. histolytica Cysts or Trophozoites in stools
With or without any of the following:
Maghs (Tenesmus)
Waja‘ al-Batn Asfal (Lower Abdominal Pain)
ĪlÄm al-Batn Asfal (Lower Abdominal Tenderness)
|
|
| ExclusionCriteria |
| Details |
1. Patients having diarrhoea with >8 stools/day
2. Moderate or severe dehydration
3. Fever (≥101 °F)
4. Patients having amoebic dysentery with any associated severe complications, e.g., fulminant colitis with perforation, paralytic ileus, toxic megacolon, ameboma, and liver abscess.
5. Clinical evidence of coexisting acute systemic illnesses
6. History or clinical evidence of chronic diseases requiring long-term treatment, e.g., DM, hypertension, tuberculosis, HIV infection, chronic liver disease, CKD, coeliac disease, IBD, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data.
7. Pregnant and lactating women
8. H/o Addiction (alcohol, drugs)
9. H/o Hypersensitivity to the study drug or any of its ingredients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Safoof-e-Teen in Zaheer (Dysentery) |
six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
six weeks |
|
|
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)
|
21/08/2018 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a multicentric open trial in patients with Zaheer (Dysentery) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at 0,1,2,4,6 weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 1 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. Composition of Safoof
Teen
|
S.
No.
|
Ingredients
|
Quantity
|
|
1.
|
Aspaghol
|
1 part
|
|
2.
|
Tukhm-e-Raihan
|
1 part
|
|
3.
|
Tukhm-e-Mako
|
1 part
|
|
4.
|
Nishasta-e-Gandum
|
1 part
|
|
5.
|
Samagh-e-Arabi
|
1 part
|
|
6.
|
Gil-e-Armani
|
1 part
|
|
7.
|
Tabasheer
|
1 part
|
|
8.
|
Tukhm-e-Hammaz Biryan
|
1 part
|
|