| CTRI Number |
CTRI/2015/10/006296 [Registered on: 23/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the medicinal effectiveness of Unani formulation “Sharbat Toot Siyah†in cases of Waram-i-Halaq (Pharyngitis) |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulation “Sharbat Toot Siyah†in cases of Waram-i-Halaq (Pharyngitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WH/STS/CLN VAL/CCRUM 14-15 Version No: 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF RAIS UR RAHMAN |
| 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
West
DELHI
110058
India |
| Phone |
9313980776 |
| Fax |
01128522965 |
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHALID M SIDDIQUI |
| Designation |
DEPUTY 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
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum507@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP KUMAR |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| 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
West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| InfrastructuralSupport:1.Regional Research Institute of Unani Medicine, Bhadrak 2.Regional Research Institute of Unani Medicine Patna, 3. Regional Research Institute of Unani Medicine Mumbai 4.Regional Research Institute of Unani Medicine Chennai 5. Regional Research Centre (RRC), Silchar 6. Clinical Research Unit Kurnool Monetary Support : Central Council for Research in Unani Medicine, New Delhi |
|
|
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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shoab Ahmad Khan |
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak |
Chand bali By pass Road
Bhadrak
ORISSA |
07205584347
drshoaibkhanbumsk@gmail.com |
| Hkm N Zaheer Ahmad |
Regional Research Institute of Unani Medicine (RRIUM), Chennai |
No.1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU |
9884764658
drnzaheer@gmail.com |
| Dr Irfan Ahmad |
Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Sir J J Hospital Compound
Mumbai
MAHARASHTRA |
09987427379
Irfanmumbai8@gmail.com |
| Dr Mrs Najmus Sehar |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Guzri, Patna City
Patna
BIHAR |
09431651861
nsehar.ccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine (RRIUM), Bhadrak |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Chennai |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J029||Acute pharyngitis, unspecified, Waram-i-Halaq (Pharyngitis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Sharbat Toot Siyah |
20 ml orally twice daily for one week
|
|
|
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 years.
2. Presence of all of the following signs and symptoms of Waram-i-Halaq (Pharyngitis):
1. Buhha al-Sawt (Hoarseness of Voice)
2. Surfa Yubsiyya (Dry Cough)
3. ‘Usr al-Bal (Dysphagia)
4. HumÄma Bul’ūm (Pharyngeal Erythema
5. Waja–e-halaq (Pain in throat).
6. Khushuna al-Halaq (Irritation in throat).
|
|
| ExclusionCriteria |
| Details |
1. Patients with all four classic symptoms of Group A Streptococcal pharyngitis:
• Pharyngeal or Tonsillar exudates
• Swollen anterior cervical nodes
• History of fever more than 380 C
• Absence of cough
2. Known cases of Renal/ Hepatic/ Cardiac ailments/ Diabetes mellitus
3. Pregnant and lactating women
4. Oral candidiasis
5. Epiglottitis,
6. Herpes Simplex
7. Mononucleosis
8. Gastro esophageal reflux
|
|
|
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 Waram-i-Halaq (Pharyngitis) |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
1 WEEK |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
02/04/2015 |
| 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) |
Open to Recruitment |
|
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 designed as a multicentric open trial in patients with Waram-i-Halaq (Pharyngitis) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed
clinically on Baseline, 3rd and 7th day of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. Composition of Sharbat Toot Siyah
|
S.
No.
|
Unani
Name
|
Scientific
Name
|
Weight
|
|
1.
|
Aab-e-Toot Siyah
|
Morusnigra Linn.
|
1litre
|
|
2.
|
Qand
Safaid
|
Honey
or sugar
|
1.5kg
|
|