| CTRI Number |
CTRI/2023/05/052675 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
15/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unani treatment for renal stones |
|
Scientific Title of Study
|
Therapeutic evaluation of Sharbat Aalu Balu in patients of ḤasÄt-ul-Bawliya (Urolithiasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaikh Muzaffar Imamsab |
| Designation |
P.G. Scholar, Department of Ilmul Jarahat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute Of Unani Medicine,Kottigepalya, Magadi Main Road
Bangalore-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9481302668 |
| Fax |
|
| Email |
shaikhmuzaffar44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Syed Shah Alam |
| Designation |
HOD and Professor, Dept. of Ilmul Jarahat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute Of Unani Medicine,Kottigepalya, Magadi Main Road
Bangalore-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8792683039 |
| Fax |
|
| Email |
shahalam1971@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Syed Shah Alam |
| Designation |
HOD and Professor, Dept. of Ilmul Jarahat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute Of Unani Medicine,Kottigepalya, Magadi Main Road
Bangalore-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8792683039 |
| Fax |
|
| Email |
shahalam1971@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine,Kottigepalya, Magadi Main Road
Bangalore-560091 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUE OF UNANI MEDICINE |
| Address |
National Institute Of Unani Medicine,Kottigepalya, Magadi Main Road
Bangalore-560091 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shaikh Muzaffar Imamsab |
National Institute of Unani Medicine |
National Institute Of Unani Medicine,Kottigepalya, Magadi Main Road
Bangalore-560091
Bangalore
KARNATAKA |
9481302668
shaikhmuzaffar44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee for Biomedical Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sharbat Aalu Balu |
Soak Aalu Balu(prunus cereus) one part in 4 parts of water for overnight and in the morning boiling will be done till the pulp softens and the volume of water remains half. Then it is cloth filtered. Mix 4 parts of sugar and citric acid (2% of sugar) will be added and the mixture will be heated .When the Qiwam (basic solution of particular consistency) of sharbat will be formed, sodium benzoate (1% of sugar) dissolved in distilled water will be added. The liquor will be filtered again and stocked in bottles.
Dosage: 25 ml with 125 ml water BD for 42 days. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with the urinary stones of size less than 10 mm diagnosed by ultrasonography of whole abdomen & pelvis esp. KUB
2. Both symptomatic & asymptomatic urolithiasis patients.
3. Only stable cases of urolithiasis will be enlisted |
|
| ExclusionCriteria |
| Details |
1. Patients having the stone of size more than 10mm
2. Severe Hydroureteronephrosis
3. Diabetes mellitus
4. Patients having any Severe Systemic Disease
5. Pregnant and lactating Women.
6. Bladder outlet obstruction |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Size of the renal stone |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain in abdomen VAS Scale)
2. Burning micturition (Yes/No)
3. Haematuria (Yes/No)
4. Nausea / Vomiting (Yes/No) |
42 days |
|
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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)
|
01/06/2023 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the past several decades, especially in developed nations, urolithiasis has become one of the most common disorders of the urinary tract across the globe, with an increase incidence and prevalence in all age groups and genders. According to estimates, at least 10% of people in affluent nations have urolithiasis and the southern part is less affected compared to other parts.UNANI PERSPECTIVE: MajÅ«sÄ« in his book kÄmilus sanÄ described that the formation of stone or gravel in urinary tract is due to shadÄ«d harÄrat and Khilt ghalÄ«z. The increased harÄrat tends to dry the moisture of the khilt ghalÄ«z resulting in the hardening and crystallization of the material leading to stone formation. According to Jalinoos, renal stone production is caused by two factors. The first cause is Qarah (ulcer) in which the pus is not be evacuated; instead, it collects in the kidney and aids in the creation of calculi. Another cause he mentions is the rÄ«h which gets entrapped in the crevices of the kidney and condenses into hard material i.e. the stone. According to Razi’s concept in the book kitab al Hawi, whenever the kidney, bladder, or joints stone develop, they are composed of lesdÄr mawÄd (a slimy substance) that is acted upon heat. As these substances cannot be excreted, they are deposited in the kidney. Due to heat the material becomes dry and dirty as the moisture gets absorbed and eventually turns it to stone. Ibn Sina has described that the stones are formed by two causes viz; GhalÄ«z mÄdÄ and retention of this ghalÄ«z mÄdÄ. The mÄdÄ gets transformed into a stone by the innate heat of the kidneys. In unani system of medicine, the major methods for the treatment of urolithiasis are lithotriptic (Mufattit-i-HasÄt) and diuretic (Mudirr-i-Bawl) medications. These facilitate the easy removal of morbid material i.e; ghalÄ«z mÄdÄ, primarily through the excretory system. Sharbat Aalu Balu is an important unani formulation, being used in urolithiasis. Sharbat Aalu Balu is diuretic and has lithotriptic properties. It also regulates urine output and is nephroprotective in nature.
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