| CTRI Number |
CTRI/2021/11/038140 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
THE STUDY OF HARITAKYADI KWATH IN TREATMENT OF HAEMATURIA |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF HARITAKYADI KWATH IN THE MANAGEMENT OF PITTAJ MUTRAKRUCHHA HAVING HAEMATURIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASIT KUMAR |
| Designation |
M S SCHOLAR SHALYA TANTRA |
| Affiliation |
Dr. D.Y. PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE |
| Address |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE
PIMPRI PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
06290262956 |
| Fax |
|
| Email |
asitkumar999ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY BABAR |
| Designation |
PROFESSOR and HOD SHALYA TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER PIMPRI PUNE |
| Address |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER
PIMPRI PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASIT KUMAR |
| Designation |
M S SCHOLAR SHALYA TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER PIMPRI PUNE |
| Address |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER
PIMPRI PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
6290262956 |
| Fax |
|
| Email |
asitkumar999ms@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR ASIT KUMAR |
| Address |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE DEEMED TO BE UNIVERSITY |
| 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 ASIT KUMAR |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER PIMPRI PUNE DEEMED TO BE UNIVERSITY |
SHALYA TANTRA OPD NO 3, Ground floor, DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER PIMPRI PUNE SANT TUKARAM NAGAR ,PIMPRI COLONY, PIMPRI CHINCHWAD 411018
Pune
MAHARASHTRA |
6290262956
asitkumar999ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
30 Patients will be selected for trial. They should not have any chronic systemic disorder |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCHHA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haritakyadi Kwath |
Route of administration : oral
Dose : 50 ml
Anupan : Honey
Time of administration : Twice daily, Before Food
Duration : 15 Days
Follow up on 0, 7, 15 day |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of Pittaj Mutrakruchha like -
> Pitta Mutrata (yellow discoloration of urine)
> Kruccha Mutrata (dysuria)
> Sadaha Mutrata (Burning sensation during Micturation)
> Sarakta mutrata (Haematuria)
> Muhur muhur Mutrata (increased frequency of urination) |
|
| ExclusionCriteria |
| Details |
> Active genital herpes
> uterine cervical vaginal urethral Cancer
> Tubercular Cystitis
> Benign or Malignant bladder Tuberculosis
> Patients having other Systemic Disorders like DM, STDs,HiV, HbsAg, Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- As per Ayurveda, Sharir is made from Doshas Dhatus and Mala. in Mutrakriccha the vitiated Pitta dosha along with Vata on reaching Basti afflicts the Mutravaha srotas due to which patients of pittaj mutrakriccha complains of peeta mutrata. Mutrakriccha is commonest health problem in community practice and common terrm called as Urinary Tract Infection or UTI.
2-To evaluate and establish safer and cost-effective Haritakyadi Kwathin the Management of Pittaj Mutrakruchha having Haematuria |
15 Days Study ( 0, 7, 15 Days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haritakyadi Kwath is effective Management of Pittaj Mutrakruccha having Haematuria |
15 days with follow up (0,7,15 days) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
24/11/2021 |
| 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
|
Aim of the study will be to give Ayurvedic Treatment to diseased patients to improve his /her conditions and we can give his/her cheap, safe side-effect free management. The trial will be conducted on 30 Patient for follow up of 0 , 7 , 15 days and dose of Drug 50 ml with honey anupan twice daily before meal duration 15 days. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study will be to give Ayurvedic Treatment to diseased patients to improve his /her conditions and we can give his/her cheap, safe side-effect free management. The trial will be conducted on 30 Patient for follow up of 0 , 7 , 15 days and dose of Drug 50 ml with honey anupan twice daily before meal duration 15 days. |