| CTRI Number |
CTRI/2022/03/041367 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
TREATMENT OF KIDNEY STONE WITH AYURVEDIC MEDICINES |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF NARIKELAPUSHPA CHURNA AND SHIGRUMULA KWADHA ALONG WITH YAVA KSHARA IN THE MANAGEMENT OF MUTRASHMARI W.S.R TO UROLITHIASIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HarithaAH |
| Designation |
P.G. Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
| Address |
OPD NO 15, Shalya Tantra DEPT,Shri Narayan Prasad Awasthi GOVT Ayurved College Raipur,(C G)
Kanchanganga phase 2, DDU nagar.RAIPUR,(C G) 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9539398246 |
| Fax |
|
| Email |
ahharithak225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balendra Singh |
| Designation |
H.O,D and Proffessor |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
| Address |
OPD NO 15, Shalya Tantra DEPT,Shri Narayan Prasad Awasthi GOVT Ayurved College RAIPUR,(C G)
Shalya Tantra DEPT,Shri Narayan Prasad Awasthi GOVT Ayurved College RAIPUR,(C G)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9039180335 |
| Fax |
|
| Email |
drbalendrasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HarithaAH |
| Designation |
P.G. Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
| Address |
OPD NO 15, Shalya Tantra DEPT,Shri Narayan Prasad Awasthi GOVT Ayurved College RAIPUR,(C G)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9539398246 |
| Fax |
|
| Email |
ahharithak225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh INDIA] |
|
|
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 HarithaAH |
SHRI KHUDADAD DUNGAJI GOVT AYURVED HOSPITAL |
OPD No 15
Shalya Tantra DEPT
Raipur
CHHATTISGARH |
9539398246
ahharithak225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: MUTRASHMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: NARIKELA PUSHPA CHURNA, Reference: BHAISHAJYA RATNAVALI 9/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -500MG YAVAKSHARA), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHIGRU MULA KWADHA, Reference: CHAKRA DUTTA 34/25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -500MG YAVAKSHARA), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group : 18-60years
Sex : Both Male and female
Size of stone : <10mm
Evidence of Urolithiasis as per USG and plain X-ray
Patient having classical feature of Asmari |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactating mother
HIV and HBsAg infection
Pyelonephritis, Hydronephrosis, Renal failure
Stag horn renal stone
Any acute urinary obstructive conditions
Uncontrolled DM, HTN, Thyroid dysfunction
Severe hepatic disease
Autoimmune disease
Patients required urgent surgical intervention |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COMPLETE CURE OF RENAL CALCULUS |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SIZE AND NUMBER OF CALCULUS WILL BE REDUCED |
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/04/2022 |
| Date of Study Completion (India) |
06/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mutrashmari is correlated with urolithiasis in modern science which is the most painful urological disorder. The high incidence of Ashmari across the world because of lack of purification and unhealthy foods and activities. It is estimated that 12% of world population experiences renal stone disease with a recurrence rate of 70%-80% in male and 47%-60% in female. Even after surgical procedures recurrence rate is very high. Postoperative complications are also reported more. So we need a cost effective conservative management with easily available drugs.Then we decided to work on such Ayurvedic formulation to find out their efficacy. So Narikela pushpa churna and Shigru mula kwath along with Yava kshara are taken to compare their action. |