| CTRI Number |
CTRI/2022/02/040349 [Registered on: 16/02/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shigru Mool Churna in Management of kidney stone. |
|
Scientific Title of Study
|
Randomized Controlled Trial of Shigru Mool Churna in Management of Mutrashmari. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshani prabhakar Gajbhiye |
| Designation |
PG scholar |
| Affiliation |
Government Ayurved college Nagpur |
| Address |
Government Ayurved college Nagpur
Sakkardara square
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9527141205 |
| Fax |
|
| Email |
gajbhiye214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Raut |
| Designation |
Professor M. D. ( Shalyatantra) |
| Affiliation |
Government Ayurved college Nagpur |
| Address |
Government Ayurved college Nagpur
Government Ayurved college Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422108928 |
| Fax |
|
| Email |
drsyraut@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Roshani prabhakar Gajbhiye |
| Designation |
PG scholar |
| Affiliation |
Government Ayurved college Nagpur |
| Address |
Government Ayurved college Nagpur
Sakkardara square
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9527141205 |
| Fax |
|
| Email |
gajbhiye214@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved hospital
Nagpur |
|
|
Primary Sponsor
|
| Name |
Roshani Gajbhiye |
| Address |
Government Ayurved college Nagpur |
| 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 |
| Roshani Gajbhiye |
Government Ayurved college and hospital Nagpur |
Shalyatantra department, Government Ayurved college,sakkardara square Nagpur.
Nagpur
MAHARASHTRA |
9527141205
gajbhiye214@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:N399||Disorder of urinary system, unspecified. Ayurveda Condition: Mutrashmari, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigrumul, Reference: Charaksamhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Normal water), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshur churn, Reference: Charaksamhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -normal water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of Age group 18-60 years.
2. Patients irrespective of gender, religion, economical, status education occupation.
3. Patient having calculi size up to 10mm in kidney, ureter and bladder.
and
4. Patients having suffering from Mutrashmari without any major illness.
5. Mutrashmari with
intervention.
no other consequences and reluctant for
6 Patient will be selected after base line investigation. 7. Co-operative patients. |
|
| ExclusionCriteria |
| Details |
1. Patient having calcull of size more than 10mm.
2. Acute retention of urine.
3. Hydronephrosis.
4. Impaired renal function.
5. Patient having severe obstructive uropathy.
6. Patient requiring emergency surgery like obstructed urinary calculi.
7. Malignancy
8. Non co-operative patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Gokshur Churna in the management of Mutrashmari. To compare the efficacy of Shigru Mool Chuma and Gokshur Churna in management of Mutrashmari. |
1 months
Size and symptoms are the parameters will be assist |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To provide alternate management principle to patient of Mutrashmari.
To study literature regarding drug and disease |
1 months |
|
|
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 |
|
Date of First Enrollment (India)
|
25/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)
|
TITAL Randomized Controlled Trial of Shigru Mool Churna in Management of Mutrashmari. Research question
Whether Shigru Mool Churna is effective in management of Mutrashmari thn Gokshur churna ? NULL HYPOTHESIS : Shigrumul churna and Gokshur churna is equally effective in the management of Mutrashmari. Alternative Hypothesis [H1]: Shigru Mool Churna is more effective than Gokshur churna in management of Mutrashimari. STANDARD OPERATING PROCEDURE GROUP A (TRIAL GROUP)
Patient will be selected from O.P.D. and I.P.D. for clinical trail of drug. At first visit of patient after screening, written consent will be taken.
observation will be recorded.
18
GROUP B (CONTROL
GROUP)
Gokshur churna
Drugs
evening before meal)
Oral
for 30days
GROUP A (TRIAL GROUP)
Shigru Mool Churna
evening before meal)
Oral
Drinking Water
Drinking water
for 30days
150 gm of Churna of Shigru Mool will be given. Patient advised to take 5gm with provided 5gm spoon at morning and evening before meal. After completion of 15 days next 150 gm power sachet with 5gm spoon will be provided.
A proforma for dairy drug consumtion diary will be provided to patient.
patient will advised to come every week so that continuity of treatment and
Patient will be advised diet regime as per instruction designed for particular study. (CONTROL GROUP)
.
Patient will be selected from O.P.D. and 1.P.D. for clinical trail of drug
At first visit of patient after screening, written consent will be taken.
150 gm of Churna of Gokshur will be given. Patient advised to take 5gm with
provided 5gm spoon at morning and evening before meal. After completion of 15
days next 150 gm power sachet with 5gm spoon will be provided.
A proforma for dairy drug consumtion diary will be provided to patient.
The patient will advised to come after a week so that continuity of treatment and
observation will be recorded. Patient will be advised diet regime as per instruction designed for particular study.
DISCUSSION:- Data obtained assessment will be analyzed and will be decided in final dissertation. CONCLUTION On the basis of available literature, observation and discussion will be precisely drawn and whole dissertation will be summarized .
4)HYPOTHESIS
Churna?
|