| CTRI Number |
CTRI/2023/08/057085 [Registered on: 30/08/2023] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [UTTAR VASTI AND SNEHAPANA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Shatavari Ghrita in management of Lower Urinary Tract Infections. |
|
Scientific Title of Study
|
A Comparative Study Of Shatavari Ghrita Uttar-Vasti And Snehapana In The Management Of Pittaja Mutrakrichhra With Special Reference To Cystitis |
| 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 Neha Chaudhary |
| Designation |
M.D. Scholar |
| Affiliation |
Government P.G. Ayurvedic college and Hospital, Varanasi |
| Address |
Department of Panchakarma, Government P.G. Ayurvedic college and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8318986643 |
| Fax |
|
| Email |
drnehachaudhary7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Government P.G. Ayurvedic college and Hospital, Varanasi |
| Address |
Department of Kayachikitsa and Panchakarma, Government P.G. Ayurvedic college and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9721217773 |
| Fax |
|
| Email |
drshwetamishraaiia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Chaudhary |
| Designation |
M.D. Scholar |
| Affiliation |
Government P.G. Ayurvedic college and Hospital, Varanasi |
| Address |
Department of Panchakarma, Government P.G. Ayurvedic college and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8318986643 |
| Fax |
|
| Email |
drnehachaudhary7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurvedic college and Hospital, Varanasi |
|
|
Primary Sponsor
|
| Name |
Government P.G. Ayurvedic college and Hospital, Varanasi |
| Address |
Department of Panchakarma, Government P.G. Ayurvedic college and Hospital, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neha Chaudhary |
Government P.G. Ayurvedic college and Hospital, Varanasi |
OPD n0. 8/10 and IPD of Kayachikitsa and Panchakarma, Government P.G. Ayurvedic college and Hospital, Varanasi
Varanasi
UTTAR PRADESH |
8318986643
drnehachaudhary7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurveda College and Hospital, Varanasi, U.P., Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N309||Cystitis, unspecified. Ayurveda Condition: PITTAJAMUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ghrita , Reference: Chakradutta Mutrakrichhra Adhyaya, Route: Oral, Dosage Form: Ghrita, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: 24ml- 48ml of Shatavari Ghrita is given to the patient early morning with Ushna jala for 7 days according to kostha and agni. | | 2 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak chikitsa 26/49, Procedure details: patient is given 24ml of shatavari ghrita through urethral route early morning for 7 days.)
(1) Medicine Name: shatavari ghrita, Reference: chakradutta mutrakrichhra adhyaya, Route: Urethral, Dosage Form: Ghrita, Dose: 24(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients are selected irrespective of Sex, Occupation, Caste, etc.
2. Patients with signs and symptoms of Pittaja Mutrakrichhra as- Raktayukta, Shulayukta, Dahayukta, Krichh- Muhurmuhur Mutrapravartti, etc are included.
3. Patients present with Pittaja mutrakrichhra as a primary complaint.
4. Patient with recurrent cystitis.
|
|
| ExclusionCriteria |
| Details |
1. Patient below age of 16 years and above 60 years.
2. Patient associated with Systemic chronic illness such as- Uncontrolled Diabetes, Acute Renal Failure, Chronic Renal Failure, Chronic Cystitis, Benign Prostate Hyperplasia, etc.
3. Pregnant women.
4. Renal calculus, Obstructive Uropathy, Poly Cystic Kidney Diseases, Glomerulo- nephritis, Nephrotic Syndrome, Urethral structure, etc.
5. STDs, PIDs, etc.
6. Cystitis as a complication of other diseases and as associated symptom of other diseases.
7. Patients in whom Snehpana is contraindicated.
8. Patients with raised lipid profile. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in pain & burning sensation while micturation |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete resolution of pain & burning micturition |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is Randomized, Parallel group study trial comparing the efficacy of Shatavari Ghrita Uttar Vasti and Snehapana in the management of Pittaja Mutrakrichhra (Cystitis). Patients will be selected randomly from OPD and IPD of Department of Kayachikitsa and Panchakarma, Government P.G. Ayurvedic College and Hospital, Varanasi. A total no. of 60 patients will be studied under two groups having 30 patients in each group- Group A: In this group, 30 patients will be treated with Shatavari Ghrita Uttar Vasti for 7 days. Group B: In this group, 30 patients will be treated with Shatavari Ghrita Snehapana for 7 days. Two follow ups will be done- First on completion of treatment i.e. on 7th day and Second follow up on 15th day in each group.
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