| CTRI Number |
CTRI/2021/06/033950 [Registered on: 02/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of acidity with Unani medicine Qurs-e-Atash |
|
Scientific Title of Study
|
An Open Label, Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial Formulation Qurs e Atash in Humuzat e Meda(Hyperacidity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HM/H/QA/CLNVAL/CCRUM/19-20, Version 2 |
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), Aligarh 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Misbahuddin Azhar |
Regional Research Institute of Unani Medicine, Aligarh |
Research OPD Room Humuzat-e-Meda(Hyperacidity) Post Box No. 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road
Aligarh
UTTAR PRADESH |
8383096715
ccrum619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R12||Heartburn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Qurs Atash |
2 tablets orally thrice daily 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. Subjects of either sex in the age group of 18-65 years
2. Subjects presenting with any of the following symptoms:
Retrosternal burning
Epigastric pain with retrosternal heaviness
Waterbrash
Anorexia
Nausea or Vomiting
SourBelching
Sour/Bitter Taste
Indigestion
Fatigue |
|
| ExclusionCriteria |
| Details |
1. Pregnant/Lactating women
2. History of previous GIT surgery
3. History of Hematemesis orMelena
4. Any systemic diseases like Cardiovascular, Respiratory, Hepato-Biliary and Renal Diseases
5. Any metabolic diseases like Diabetes
6. Chronic tobacco chewers or smokers
7. Alcoholism
8. Allergy/Hypersensitivity to any ingredients of the drug.
9. Known cases of Peptic Ulcer disease, Crohn’s Disease, Zollinger-Ellison Syndrome and Carcinoma of gastro-intestinal tract |
|
|
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 Humuzat-e-Meda(Hyperacidity) |
2weeks |
|
|
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="110"
Sample Size from India="110"
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)
|
07/06/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single arm trial in patients with Humuzat-e-Meda (Hyperacididty). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Qurs-e-Atash two tablets thrice daily with water after meals for six weeks. The patients will be assessed 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 Qurs Atash | S. No. | Ingredients | Botanical Name | Quantity | | 1 | Maghz-e-Tukhm-e-Kaddu | Cucurbitamoschata | 40g | | 2 | Maghz-e-Tukhm-e-Khiyarain | CucumissativusLinn. CucumismeloLinn. | 40g | | 3 | Maghz-e-Tukhm-e-Khiyar | CucumissativusLinn. | 40g | | 4 | Tukhm-e-Khurfa | Portulacaoleracea | 40g | | 5 | Samagh-e-Arbi | Acacia Arabica | 20g | | 6 | Nishasta | Carbohydrate | 20g | | 7 | Kateera | CochlospermumreligiosumLinn. | 20g | | 8 | Sandal Safaid | Santalum album Linn. | 20g | | 9 | Kafoor | Cinnamomumcamphora | 5g | | 10 | Loab-e-Aspaghol | Plantagoovata | Q.S. | | 11 | Ma-ul-Shaeer | Barley Water | Q.S. | | 12 | Aab-e-Kaddu | Water of Cucurbitamoschata | Q.S. | |