| CTRI Number |
CTRI/2024/07/071693 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study To Assess The Efficacy Of Amlikakshar In Management of Mutrakrucchra With Special Reference To Urinary Tract Infection |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Assess The Efficacy Of Amlikakshar In Management of Mutrakrucchra With Special Reference To Urinary Tract Infection |
| 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 Aishwarya Dilip Chavan |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Department of Shalyatatra , Division 1, Room no 1, Islampur Sangli.
Sangli
MAHARASHTRA
415409
India |
| Phone |
9011368573 |
| Fax |
|
| Email |
chavanaishwarya777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramchandra Shedge |
| Designation |
HOD Professor in Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Department of Shalyatantra , Division 1, Room no 1, Islampur Sangli.
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Ramchandra Shedge |
| Designation |
HOD Professor in Shalyatantra Department |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Department of Shalyatantra , Division 1, Room no 1, Islampur Sangli.
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Dilip Chavan |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli |
| 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 |
| Dr Aishwarya Dilip Chavan |
LRP Ayurvedic Medical College |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Department of Shalyatatra , Division 1, Room no 1, Islampur Sangli.
Sangli
MAHARASHTRA |
9011368573
chavanaishwarya777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N300||Acute cystitis. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amlikakshar, Reference: Ras Tarangini 13th tarang, Route: Oral, Dosage Form: Kshara , Dose: 625(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Yavakshar, Reference: Ras tarangini 13th tarang, Route: Oral, Dosage Form: Kshara , Dose: 625(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Patients having sign and symptoms of Mutrakruchra (Sadaha,
Saruja Mutrapravruti).
2. The age group between 18 to 60 years.
3. Patients irrespective of religion, sex and economical status |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Pregnancy & lactation
2. Prostate enlargement
3. Patients who having known case of any part of urinary tract,
Renal failure, chronic kidney diseases, Renal calculus, Nephritis,
Pyelonephritis.
4. Phimosis or paraphimosis.
5. Patients having known case of systemic illness like DM, HTN,
Asthma, HIV, HbsAg.
6. Patients who having autoimmune disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
STUDY TO ASSESS THE EFFICACY OF
AMLIKAKSHAR IN MANAGEMENT OF MUTRAKRUCCHRA WITH SPECIAL
REFERENCE TO URINARY TRACT INFECTION IN AGE GROUP OF 18-60 FOR 15 DAYS
TO REDUCE THE SYMPTOMS OF URINARY TRACT INFECTION |
15 days study
follow up 1st, 2nd, 3rd, 4th, 5th, 6th,10th,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
STUDY TO ASSESS THE EFFICACY OF
AMLIKAKSHAR IN MANAGEMENT OF MUTRAKRUCCHRA WITH SPECIAL
REFERENCE TO URINARY TRACT INFECTION IN AGE GROUP OF 18-60 FOR 15 DAYS
TO REDUCE THE SYMPTOMS OF URINARY TRACT INFECTION |
15 days study
follow up 1st, 2nd, 3rd, 4th, 5th, 6th,10th,15th days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/08/2024 |
| 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="0"
Months="6"
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
|
The term Mutrakruchhra comes under the disorders of Mutravaha Srotas, description of this disease is mentioned in almost all classical texts. Mutra is an outcome product of digestion of food and metabolism in the body it is passes through urethra. Acharya Charaka has described eight types of Mutrakruchhra. Charaka has also mentioned eight type of Mutraghata. Mutraghata and Mutrakruchhra separately described by Acharya Sushruta in Uttar-tantra. In Mutrakruchhra, the vitiated Pitta Dosha along with Vata (mainly Apana Vayu) on reaching basti (bladder) affects the Mutravaha Srotas due to which the patient feels difficulty in micturition along with symptoms like Krucchra mutrata, Saraktamutrata, Sadahamutrata, Sarujamutrata and Muhur-muhurmutrata. It can be concluded that vyayama, vishamasan, rukshasevana, yanagamana are causative factors for vataprakopa6 Tikshnaaushadha, amla sevana causes pitta prakopa and Anupamansasevana, avyayama, adhyashan causes kaphaprakopa So these Nidanas cause vitiation of Doshas along with Stroto-dushti of Mutrvahastrotas. Stroto-dusti will cause kha-vaigunya in Mutravahasrotas. These factor leads to Mutrakrucchra. The lakshanas of mutrakruchra such as peetmutrata, sarakta mutrata, sarujamutrata, kruchramutrata, muhur muhur mutrata are very much resembles to signs and symptoms of urinary tract infection. A healthy urinary tract is generally resistant to infections. However, for anatomical reasons female lower urinary tract is more susceptible. Predisposing factors for recurrent Urinary tract infection include female sex, obstructive uropathy, severe vesico ureteric reflux, constipation, repeated catheterization poor hygienic conditions, environment, poverty and illiteracy also contribute to the increasing percentage of urinary tract infections. Ayurveda samhitas have described many herbs that work on mutravahastrotasdushti. Taking all these in consideration, I have selected Amlikakshar which has special reference of giving it in Mutakrucchra. This kshar is easily available and economically affordable. |