| CTRI Number |
CTRI/2022/10/046645 [Registered on: 19/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of kidney stone with Unani medicine Jawarish Zarooni Sada |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Jawarish Zarooni Sada in HasÄh al-Kulya (Nephrolithiasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HK/N/JZS/CLNVAL/CCRUM /21-22, version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Central Research Institute of Unani Medicine (CRIUM), Lucknow Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 Shamsul Arfeen |
Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Research OPD Room (HasÄh al-Kulya) Vill. and Post Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
9450389873
sarfeen0110@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jawarish Zarooni Sada |
5gm orally to be taken orally twice daily with water after meals for 8 weeks |
| Comparator Agent |
NIl |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender in the age group 18-65 years.
2. Patients with HasÄh al-Kulya (Nephrolithiasis) as diagnosed by USG (KUB) with calculi
measuring up to 5 mm (single or multiple) with or without any of the following symptoms:
Pain or heaviness in flank region
Pain or heaviness in groin/loin region
Urinary urgency
Nausea and vomiting |
|
| ExclusionCriteria |
| Details |
1. Size of calculi above 5 mm
2. Patients with Renal colic and Hydronephrosis
3. Patients having impacted stones
4. Previous history of stone surgery
5. Patients with signs of renal failure
6. Pregnant and lactating women
7. Known cases of Hepatic, Renal or Cardiac ailments
8. Patients having systemic disease requiring long term treatment like Diabetes mellitus,
Hypertension etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The efficacy of the drug will be assessed on the basis of following parameters:
1. Clinical Parameters i.e. Reduction in signs and symptoms.
2. Radiological Parameters- Ultrasound KUB will be taken as criteria for detection of reduction in stone size or expulsion of stone.
3. Frequency of Rescue medication used during the protocol duration.
4. Classical Examination of Urine (Nazri Muana-e-Bawl) |
At baseline, 2, 4, 6 and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline, 4 and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
26/10/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single centric open trial in patients with HasÄh al-Kulya (Nephrolithiasis). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 8 weeks. Laboratory parameters for safety assessment will be conducted at baseline, 4 weeks and on completion of the protocol therapy.
Composition of Jawarish Zarooni Sada | S. No. | Name of the drug | Scientific name | Quantity | | 1. | Tukhm-e-Gajar | Daucus carota Linn. | 30gms | | 2. | Tukhm-e-Karafs | Apium graveolens L. seeds | 30gms | | 3. | Tukhm-e-Ispat | Trifolium alexandrinum | 30gms | | 4. | Nankhwah | Trachyspermum ammi L. | 30gms | | 5. | Badiyan | Foeniculum vulgare M. | 30gms | | 6. | Maghz-e-Tukhm-e- Kharbuz | Cucumis melo L. | 30gms | | 7. | Maghz-e-Tukhm-Khiyarain | Cucumis sativus L. | 30gms | | 8. | Post-e-Beekh-e-Karafs | Apium graveolens L. root | 30gms | | 9. | Qaranful | Syzygium aromaticum L. | 30gms | | 10. | FilfilSiyah | Piper nigrum L. | 30gms | | 11. | Aaqarqarha | Anacyclus pyrethrum DC. | 10gms | | 12. | Darchini | Cinnamomum zeylanicum | 10gms | | 13. | Zafran | Crocus sativus L. | 10gms | | 14. | Mastagi | Pistacia lentiscus L. | 10gms | | 15. | Ood Hindi | Aquilaria agallocha R. | 10gms | | 16. | Bisbasa | Myristica fragrans H.; fruit rind | 10gms | | 17. | Asal or Qand Safaid | Honey or Sugar | 1kg |
|