| CTRI Number |
CTRI/2022/10/046928 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
29/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Dry Cupping] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of effects of Hijama- Bila- Shurt (Dry Cupping) as a part of multimodal approach in the management of fibromyalgia. |
|
Scientific Title of Study
|
Clinical evaluation of effects of Hijama- Bila- Shurt (Dry Cupping) as a part of multimodal approach in the management of fibromyalgia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMAYYA PARVEZ |
| Designation |
PG Scholar |
| Affiliation |
Department of Ilaj bit tadbeer Ajmal khan Tibbiya college Aligarh Muslim University Aligarh |
| Address |
Department Of Ilaj bit Tadbeer,Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001
Department Of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8273388467 |
| Fax |
|
| Email |
parvezsumayya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfMohd Anwar |
| Designation |
Professor |
| Affiliation |
Department of Ilaj bit tadbeer Ajmal khan Tibbiya college Aligarh Muslim University Aligarh |
| Address |
Department Of Ilaj bit Tadbeer,Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001
Department Of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8979224254 |
| Fax |
|
| Email |
mohdanwarnium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUMAYYA PARVEZ |
| Designation |
PG Scholar |
| Affiliation |
Department of Ilaj bit tadbeer Ajmal khan Tibbiya college Aligarh Muslim University Aligarh |
| Address |
Department Of Ilaj bit Tadbeer,Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001
Department Of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8273388467 |
| Fax |
|
| Email |
parvezsumayya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Ilaj bit Tadbeer,Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh |
|
|
Primary Sponsor
|
| Name |
Ajmal Khan Tibbiya College |
| Address |
Department Of Ilaj bit Tadbeer,Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh 202001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sumayya Parvez |
Ajmal Khan Tibbiya College |
Department of Ilaj Bit Tadbeer AKTC AMU Aligarh
Aligarh
UTTAR PRADESH |
8273388467
parvezsumayya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amitryptiline 10 mg and Habbe Asgandh |
Amitriptiline is used to treat Psychosomatic conditions and Habbe asgandh is used as an analgesic,anti inflammatory,anti depressant,anxiolytic agent. |
| Intervention |
Dry cupping and Habbe Asgandh |
Intervention group A:
• Application of Dry Cupping (Hijamah Bila Shurt) once in a week on tender points for 10 minutes for total of 4 weeks.
Intervention group B:
• Application of Dry Cupping (Hijamah –Bila- Shurt) once in a week on tender points for 10 minutes for total of 4 weeks and Patients will be asked to take 2 tablets (650 mg each) of Habb-e- Asgandh orally twice daily an hour after meals for four weeks.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically Diagnosed patient of FMS (Based on 2016 revision of American College of Rheumatology (ACR) Diagnostic Criteria of 2011/2010.
2. Patients who are able to give written informed consent and follow the protocol of study.
3. Patients of either sex
4. Patients in age group of 20-60 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 20 years and above 60 years
2. Primary generalized osteoarthritis, polymyalgia rheumatica, Rheumatoid arthritis, Diabetic Neuropathy,Hypothyroidism
Pregnant and Lactating women
4. Patients with uncontrolled diabetes and severe hypertension.
5. Patient taking medicine for any other psycho- somatic disorders.
6. History of trauma.
7. Patients having anemia(Hb% less than 9gm%).
8. Patients unable to give informed written consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement Criteria- it will be correlated with the subjective and objective parameters.
1.Primary Parameters
• NRS (Numeric Rating Scale)
0-no pain to 10-worst possible pain
|
Every 14th day for 28 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Secondary Parameters:
1.Revised Fibromyalgia Impact Questionaire(FIQR)
2.Requirement of acetaminophen(650mg) on weekly basis.
|
Every 14th day for 28 days
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/11/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinical evaluation of effects of Hijama- Bila- Shurt (Dry Cupping) as a part of multimodal approach in the management of fibromyalgia. |