| CTRI Number |
CTRI/2025/01/079257 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effectiveness of Hammam i Murattib Ustukhudus and Sibr in Parkinsons Disease |
|
Scientific Title of Study
|
Efficacy of Hammam i Murattib and Ustukhudus with Sibr as an Adjuvant in Parkinsons Disease A Randomized Assessor Blinded Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Najeeb |
| Designation |
PG Scholar Department of Ilaj Bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8982533834 |
| Fax |
|
| Email |
mnajeeb1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Associate Professor Department of Ilaj Bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9035417278 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Associate Professor Department of Ilaj Bit Tadbeer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9035417278 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine Kottigepalya, Magadi Main Road Bengaluru 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 karnataka India |
| 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 Mohammad Najeeb |
National Institute of Unani Medicine |
Department of Ilaj Bit Tadbeer OPD No 28 National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 karnataka India
Bangalore
KARNATAKA |
8982533834
mnajeeb1996@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: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbidopa levodopa (300-1000mg/day) alone |
Tablet Carbidopa levodopa 300-1000mg will be administered orally daily prescibed by the physician |
| Intervention |
Hammam i Murattib and Ustukhudus (Lavandula stoechas L.) with Sibr (aloe barbadensis) along with carbidopa-levodopa (300-1000mg/day). |
After identification and authentication of the drug, Ustukhudus (Lavandula stoechas L.) and Sibr (aloe) will be taken in equal ratio pounded, sieved and mixed well to make a homogenous powder. Orally 7gm powder will be given in two divided doses for 35 days.The Hammam area is prepared by heating the room and adding water to generate steam. Participants need to drink water to stay hydrated. Participant in group A will undergo Hammam i Murattib on a regular basis for 35 days. The Hammam will be done by following the standard operative procedure. Participant will be taken in the 1st room (Moatadil) where they must stay for few minutes so that he can adapt the temperament of first room and then gradually shifted to the second room (Har Ratab or Hot and Wet) where he had to sit or recline comfortably, allowing the steam to envelop him. The duration of the 2nd room will be 30 minutes. After the end of Hammam participants should cover himself with a towel or cloth properly and should return to 1st room (Moatadil) gradually and stay for some time till the temperature of body becomes normal |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of Idiopathic Parkinson’s Disease (PD) with Yahr staging (Hoehn and yahr scale) equal or less than 3.
Patients having the age between 30 and 70 years with either gender having initiation of PD symptoms not more than six years.
No treatment change within four weeks before the intervention start.
Patient who are willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Patients taking selective serotonin reuptake inhibitors (SSRIs), and monoamine oxidase inhibitors (MAOIs).
Patients with severe systemic disease Patients who suffered from any complication of standard treatment of PD, including urticaria, pruritus, nausea, vomiting, vertigo, etc.
Pregnant and lactating women.
Patients who fail to follow up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unified Parkinson’s Disease rating scale (UPDRS) Part I + II + III |
At baseline, 12th day, 24th day and 35th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 12-Item Short Form Survey (SF-12) |
At baseline, 12th day, 24th day and 35th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/02/2025 |
| 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 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
|
Parkinson’s disease (PD) is a common
age-related neurodegenerative disorder characterized by motor symptoms such as
tremors, stiffness, and slowness of movement, as well as non-motor symptoms
like cognitive impairment and mood disorders. PD is the second-most
common neurodegenerative disorder that could affect 1–2/1000 of the population
at any time, and its prevalence is increasing along with age increasing. This
disease affects 1–3% of the population with more than 65 years old.
Pharmacological management of PD
could involve administration of levodopa, dopamine agonists, Monoamine oxidase
B (MAO-B) Inhibitors, anticholinergics, amantadine and/or Catechol-O-methyltransferase
(COMT) Inhibitors. None of these medications has been acted convincingly in
order to decelerate or stop the PD progression.
In Unani literature, there is a description
of same disease by different name such as Rasha, Istirkha Wa Falij, Zouf-i-Aasab, Zouf-i-Quwa, Ikhtelaj-i-Azlat, Burudat-i-Azlat etc.
Parkinsonian tremors can be well visualized in the context of: Rasha as
it is one of the essential aspects of Parkinsonism.
In
unani literature, Ustukhudus and Sibr is reported as a nerve tonic and
neuroprotective agent, and its preparations are recommended for some neurologic
disorders. However, the possible useful effects of Ustukhudus and Sibr on
Parkinson’s disease (PD) have not been evaluated, yet. Hence,
Ustukhudus
(Lavandula stoechas L.) and Sibr (aloe) has been chosen as a study drug among the various medications for management
of Parkinson as both possess Munaqqi-i-Dimagh, Muqawwi-i-Asab, Mushil-i-Balgham, Mushil-i-Sawda, Muharrik-i-Asab. Along with the drug administration Ilaj bit tadbeer is one of the
effective modes of treatment that has been described in Unani system of medicine.
In which Hammam is one of the famous regimens practiced all over the world
since antiquity. Hammam therapy for the treatment of motor and non-motor
symptoms in patients with early-stage PD can have favorable results in terms of
slowed movement, dystonia, balance, pain, quality of life, and physical function.
The study emphasizes the need for further validation of the
biological mechanisms through which these drugs and therapy reduce the symptoms and signs of
Parkinson’s disease. Hence, it has been decided
to conduct a clinical study
to determine the Efficacy of Hammam-i-Murattib
and Ustukhudus (Lavandula
stoechas L.) with Sibr (Aloe barbadensis) in patient with Parkinson’s disease.
|