| CTRI Number |
CTRI/2024/08/072106 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Mughat(Unani single drug) in disease of skeletal muscle weakness |
|
Scientific Title of Study
|
Efficacy of Moghat in Sarcopenia among elderly; A randomized placebo-controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHD MUZAMMIL MOHD IBRAHIM |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept of Tahaffuzi wa Samaji Tib ,National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bangalore, Karnataka-560091, India.
Bangalore
KARNATAKA
560091
India |
| Phone |
7448187492 |
| Fax |
|
| Email |
muzammil.mku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zarnigar |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept of Tahaffuzi wa Samaji Tib,National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bangalore, Karnataka-560091, India.
Bangalore
KARNATAKA
560091
India |
| Phone |
7483244027 |
| Fax |
|
| Email |
kzarnigar15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Muzammil Mohd Ibrahim |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept of Tahaffuzi wa Samaji Tib,National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bangalore, Karnataka-560091 India.
Bangalore
KARNATAKA
560091
India |
| Phone |
7448187492 |
| Fax |
|
| Email |
muzammil.mku@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. Tahaffuzi wa samaji Tib, OPD (room no 3) and IPD of National Institute of Unani Medicine hospital,Bangalore,Karnataka,India-560091. |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bangalore, Karnataka, India-560091 |
| 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 |
| Dr Mohd Muzammil Mohd Ibrahim |
National Institute of Unani Medicine Hospital |
OPD no.03 Dept of tahaffuzi wa samaji tib,OPD Block,Kottigepalya Magadi Main Road Bangalore,Karnataka,India-560091
Bangalore
KARNATAKA |
7448187492
muzammil.mku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mughat |
The drug will be identified in crude form. The drug will be cleaned to remove any unwanted material and impurities and then powdered. 7gram coarsely powdered drug has to be soaked in 2 cups of water approx 400ml for 10 to 12 hrs. then boil until the original volume is reduce to its half 1 cup approx 200ml. Strain out the herb using a filter and the filtrate obtained will be consumed as a whole 2 times a day for 60 days. |
| Comparator Agent |
Wheat flour |
Wheat flour will be used as placebo control in another group in the 7gms twice a day for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1 Age less than and equal to 60 years
2 Grip Strength in Men less than 27 and in Women less than 16
3 Gait Speed less than and equal to 0.8 meter per second
4 Time up and go test(time needed to rise from seated and walk 3 meter away and back with return to seated) less than 20 seconds
5 SPPB(short physical performance Battery) less than 8 points
A Standing Balance
a)Side by side stand feet in parallel paired position for 10 sec
b)Semi tandem stand feet in parallel non paired position for 10 sec
c Tandem stand test (put one foot Infront of other)
B 4meter walking speed
C Chair stand test
[Total SPPB Score will be obtain by adding the scores of standing balance test, gait speed test and chair stands test] |
|
| ExclusionCriteria |
| Details |
1 Age younger than 60 years
2 Protein-calorie malabsorption(Celiac disease,Crohn’s disease,Tropical sprue, Whipple’s disease,Chronic pancreatitis,cystic fibrosis,Biliary cirrhosis,primary sclerosing cholangitis,Intestinal tuberculosis,Intestinal lymphangiectasia,Intestinal lymphoma)
3 Presence of morbidity(uncontrolled hypertension,and type 2 Diabetes Mellitus, neurologic disorders,metabolic diseases, rheumatic diseases,heart failure,severe chronic obstructive pulmonary disease (COPD), hemocoagulation syndromes, terminal cancer, severe renal diseases, Poor Controlled psychiatric disease such as schizophrenia, and blindness)
4 Use of medication(immunosuppressive drugs, insulin)
5 Immobilization for 1 week during the last 3 months,
Patients with acute immobility(i.e. post hip fracture or post-acute hospital admission) should be excluded, orthopedic surgery during the last 2 years or still causing pain or functional limitation
6 Highly trained athletes were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in muscle strength by using Grip Strength,Gait Speed,Time up and go test,SPPB (short physical performance Battery) |
at Baseline, 30th day , 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Efficacy
1.Upper arm circumference
2.Calf circumference
3.Thigh circumference
4.Grip strength
5.Body weight
6.Timed & climbs of flight of stairs (4 to 11)
7.Skin fold thickness
8.Gait speed
9.Time up & go test
10. 6 MWD(6 minute walk distance)
11.30 second chair stand test
12.Range of motion
13.Complete hemogram |
at Baseline & 60th day. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sarcopenia is a musculoskeletal disease generally
defined by the progressive loss of muscle mass and strength, particularly in
elderly populations.The diagnosis of sarcopenia encompasses
decreased levels of the following 3 traits: Muscle strength, muscle quantity or
quality, and physical performance.
Sarcopenia
is a type of muscle atrophy primarily caused by the natural aging process.
Scientists believe being physically inactive and eating an unhealthy diet can
contribute to the disease.
Sarcopenia is strongly associated with a greater
incidence of falls and increased fracture risk.Furthermore, decreased muscle mass or
muscle function, both criteria for sarcopenia, are risk factors for loss of
independence in patients over the age of 90 years old.
The prevalence of sarcopenia is estimated
within the ranges of 5 – 13% and 11 – 50% in patients aged 60 and above,
and 80 and above, respectively.The worldwide prevalence of sarcopenia in patients over
the age of 60 is estimated to be 10%.Variations observed among studies are
likely due to inconsistent diagnostic criteria, and heterogeneous populations studied.
Sarcopenia almost exclusively affects elderly populations and affects both
sexes equally.Data regarding sarcopenia and ethnicity is
inconsistent among studies. Furthermore, the prevalence of sarcopenia is
greater in patients with chronic diseases such as COPD, CHF, CKD, DM, HIV, and
Cancer.
Sarcopenia
presents a great financial burden on the field of healthcare, as well as
decreased quality of life in those who suffer from it. Early detection and
management/treatment of sarcopenia reduce these burdens and improve the
outcomes of the condition.Currently, the most effective modalities available to fight sarcopenia are
physical activity and nutrition optimization.
Unani physicians recommend exercise, massage, hammam, mulattif and
mufatteh sudud aghzia and advia for health promotion of elderly and prevention
of sarcopenia. Unani physicians used har
ratab muqawwi azla and musammine badan formulations and single drugs for the
treatment of Huzal in elderly. Among which Moghat is an effective one but is
not scientifically explored so far. Therefore, this study has been designed to
evaluate the efficacy of Moghat in Sarcopenia (Huzal in elderly). |