| CTRI Number |
CTRI/2024/07/070601 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy Evaluation of Unani Formulation in the Management of Baul Fil-Firash (Nocturnal Enuresis) |
|
Scientific Title of Study
|
Efficacy Evaluation of Unani Formulation in the Management of Baul Fil-Firash (Nocturnal Enuresis) A Randomized single blind placebo-controlled Study |
| 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 Saiyeda Zainab Fatima |
| Designation |
Post Graduate Scholar |
| Affiliation |
State Unani Medical College |
| Address |
Department of Ilmul Atfal, State Unani Medical College, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8933020509 |
| Fax |
|
| Email |
zainab.fatima778@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MD SOHAIL |
| Designation |
Assistant Professor and Head of Department In-charge |
| Affiliation |
State Unani Medical College |
| Address |
Department of Ilmul Atfal, State Unani Medical College, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279944096 |
| Fax |
|
| Email |
shlt869@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MD SOHAIL |
| Designation |
Assistant Professor and Head of Department In-charge |
| Affiliation |
State Unani Medical College |
| Address |
Department of Ilmul Atfal, State Unani Medical College, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279944096 |
| Fax |
|
| Email |
shlt869@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital, Himmatganj, Prayagraj,UP, India 211016 |
|
|
Primary Sponsor
|
| Name |
Saiyeda Zainab Fatima |
| Address |
Department of Ilmul Atfal, State Unani Medical College and Hospital, Himmatganj, Prayagraj, UP, India 211016 |
| Type of Sponsor |
Other [Self] |
|
|
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 Saiyeda Zainab Fatima |
State Unani Medical College |
OPD No 2,Department of Ilmul Atfal, State Unani Medical College,Himmatganj, Prayagraj, UP
Allahabad
UTTAR PRADESH |
8933020509
zainab.fatima778@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: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
3-5 gm Roasted Suji with powdered sugar orally twice a day for 45 days |
| Intervention |
Unani formulation: Punica granulatum, Tamarix gallica, Coriandrum sativum, Accacia arabica, Boswellia serrata, Quercus incana |
3-5 gm of safoof (Powder) of Unani Formulation given orally twice a day for 45 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are fulfilling DSM-5 Criteria as mentioned below:
1. Involuntary or intentional, repeated voiding of urine into bed or clothes.
2. The behaviour should be clinically significant as manifested by either a frequency of twice a week for at least 3 consecutive months or the presence of clinically significant distress or impairment in social, academic (occupational), or other important areas of functioning.
3. Chronological age is at least 5-years.
4. The behaviour is not due exclusively to the direct physiological effect of a substance (e.g. a diuretic or an antipsychotic medication) or another medical condition(e.g.Diabetes, Spina bifida, a seizure disorder) |
|
| ExclusionCriteria |
| Details |
1. Patient below 5 years
2. Patient above 14 years
3. Patient with anatomical malformation such as hypospadias
4. Mental Impairment
5. Urinary Tract Infection
6. Known case of diabetes insipidus
7. Diabetes mellitus type 1 and type 2
8. Patient guardian who fails to give consent
9. Patient who fails to follow up |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the frequency of involuntary voiding of urine during night |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in other symptoms like shamefulness, fear, Aggressiveness, Irritability |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
08/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Baul Fil-Firash (Nocturnal Enuresis) Composed of Arabic words- “Al-Baul†and “Al-Firash†Which stand for urine and bed respectively.
Nocturnal Enuresis (Baul
Fil-Firash) refers to involuntary voiding in night in children aged 5 years
or more without any other urinary tract symptoms. The prevalence of Nocturnal
Enuresis is more than 10% among 6 years old and 5% among 10 years old &
0.5-1% among teenagers & young adults. Nocturnal Enuresis has a Negative
impact on Child`s health and imposes a long-term burden on families. It causes negative psychological consequences
& behavioural problems.
Although Nocturnal Enuresis has a high rate of spontaneous remission
but it affects quality of life and self-confidence of children. Anti-cholinergic
drugs and muscle relaxants are used in the management but relapse is noticed in
majority of children after discontinuation of drugs.
Despite being a common problem, evidence of safe
and effective treatment is not available. Unani physicians are treating this
disease successfully from decades so clinical trials on Scientific parameters
are required to evaluate efficacy of the Unani compound formulation. Nocturnal Enuresis refers to the symptoms of intermittent
incontinence during sleep at least twice a week in children older than 5 years
of age for at least 3 months. In other words, any type of wetting episodes that occur in discrete amount
during sleep is called Nocturnal
Enuresis. In Unani system of Medicine Nocturnal enuresis is mentioned as Baul Fil-Firash / Baul Bistari / Khwab me
Peshab Nikal Jana. It is the condition in which there is voiding during sleep. (Neend me Peshab khata ho jana). It is
due to altered temperament of bladder and flaccidity in muscles of urinary
bladder (Masana ki Sardi aur Azla ka
Isterkha) This condition is seen more among boys.
As mentioned in various Unani literature cause
of Baul Fil-Firash is “Isterkha†of urinary bladder which means
loosening of muscle tone of Bladder. Another cause is Ratubat which means Moistening of bladder and altered temperament
of bladder which causes loosening of muscle fibre. |