| CTRI Number |
CTRI/2021/12/038795 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
20/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Sū’al-Qinya (low hemoglobin level in blood) with Unani medicine Qurs-e-Zarishk |
|
Scientific Title of Study
|
An open-label, Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial formulation – Qurs-e-Zarishk in Sū’al-Qinya (Anemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SQ/A/QZ/CLNVAL/CCRUM 19-20, version 02 |
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 National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad 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 Arzeena Jabeen |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
Research OPD Sū’al-Qinya (Anemia),AG Colony Rd, Sunder Nagar
Hyderabad
TELANGANA |
9032519286
aarzu763@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D500||Iron deficiency anemia secondary to blood loss (chronic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Qurs-e-Zarishk |
Majoon-e- Ushba 2tablets Thrice daily Orally with water for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Hb% <12 gm/dl but > 8 gm/dl
2. Female patients in the age group of 18-65 years
3. With or without following complaints:
Fatigue
General weakness
Dizziness
Palpitation
Breathlessness
Restless leg syndrome
Thumping or whooshing sound in ear
Loss of appetite
Chest pain
Fainting |
|
| ExclusionCriteria |
| Details |
1. Concomitant medications or history of blood transfusion within prior to 120 days.
2. Known case of any severesystemic diseases such as allergic asthma, chronic kidney diseases, auto-immune disorders(SLE, RA, ulcerative colitis), heart diseases and canceretc.
3. Known cases of any other acute illness.
4. Known case ofhemogolobinopathy or other red celldisordersThalassemias, sickle cell anemia, congenital dyserythropoietic anemia etc.
5. History of hypersensitivity to the investigational drug or herbal drugs.
6. Pregnant and nursing women. |
|
|
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 Sū’al-Qinya (Anemia) |
12weeks |
|
|
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)
|
27/12/2021 |
| 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 multicentric open trial in patients with Sū’al-Qinya (Anemia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Qurs-e-Zarishk two tablets thrice daily with water for 12 weeks. The patients will be assessed at every 14 days. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. | S. No | Name of the Drug | Scientific Name | Quantity in gm | | 1. | Zarishk (seed) | Berberisaristata D.C | 40 | | 2. | RewandChini | Rheum emodi Wall. | 10 | | 3. | Gul-e-Surkh | Rosa damascena Mill. | 10 | | 4. | Maghz-e-Tukhm-e-Khiyarain | Cucumissativus L. & CucumisutilissimusRoxb. | 10 | | 5. | Sandal Safaid | Santalum album L. | 10 | | 6. | Tukhm-e-Kasni | Cichoriumintybus L. | 10 | | 7. | LukMaghsool | Coccuslacca | 5 | | 8. | Asl-us-Soos | Glycyrhizaglabra L. | 5 | | 9. | Gul-e-Nilofar | Nymphae alba L. | 5 | | 10. | Tabasheer | BambusabambosDruce. | 5 | |