| CTRI Number |
CTRI/2025/08/092359 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of dhaniya paanaka and Pranayam on urinary tract infection |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate Effect of Gokshura Churna And Dhanya Paanaka (As Pathya) and Sheetali Pranayam on Pittaja Mutrakrichra |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Hiremath |
| Designation |
Ph.D scholar |
| Affiliation |
GURU Ravidass Ayurved University |
| Address |
Government Ayurvedic college Moti Bagh
Patiala
GURU RAVIDAS AYURVED UNIVERSITY una Road,VPO,Kharkov,Hoshiarpur Punjab 1461101
Hoshiarpur
PUNJAB
147001
India |
| Phone |
9592986167 |
| Fax |
|
| Email |
drjyotih009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Sharma |
| Designation |
Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Chandigarh |
| Address |
Shri Dhanwantry Ayurvedic College And Hospital 77,Chandigarh path,46B,sector 46, Chandigarh 160047
Shri Dhanwantry Ayurvedic College And Hospital 77,Chandigarh path,46B,sector 46, Chandigarh 160047
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
|
| Email |
neerjasharma2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neerja Sharma |
| Designation |
Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Chandigarh |
| Address |
Shri Dhanwantry Ayurvedic College And Hospital 77,Chandigarh path,46B,sector 46, Chandigarh 160047
Shri Dhanwantry Ayurvedic College And Hospital 77,Chandigarh path,46B,sector 46, Chandigarh 160047
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
|
| Email |
neerjasharma2966@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jyoti Hiremath |
| Address |
Government Ayurvedic college Moti bagh patiala, Punjab India 147001 |
| Type of Sponsor |
Other [[ self sponsered doing Ph.D from Government University and I conduct my trials in my working place] |
|
|
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 |
| Jyoti Hiremath |
Government Ayurvedic hospital Patiala Punjab 147001 |
Government Ayurvedic hospital, department of swasthavritta, room number 6,Patiala Punjab 147001
Patiala
PUNJAB |
09592986167
drjyotih009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N390||Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | dhanya paanak along with pranayam | (Procedure Reference: yogarantakara and hatha yoga pradipika, Procedure details: dhanya paanak 100ml Bd (yogaratnakar paanakani V:7) followed by sheetali pranayam (Hathayoga pradipika ch:2,V58) 18 minutes duration of the intervention consists of three 5 minutes epochs with 3 period of 1 minute rest in between the 3 epochs.This complete procedure is done for 21 days there is one follow up after 10 days & total duration of study is 31 days
)
(1) Medicine Name: dhanya, Reference: yogarantakar, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 100(ml), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: gokshura, Reference: A.F.I-1, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 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 |
The diagnosed patient of Pittaja Mutrakrichra according to classical signs and symptoms
Patients who are giving consent to study. |
|
| ExclusionCriteria |
| Details |
Patients with STD( Sexually Transmitted Diseases)
If congenital anomaly of kidney, ureter, urinary bladder, or urethra.
Patients with systemic disorders DM,CRF.
Case of associated obstructed uropathy and Suffering from chronic illness
Lactating mother and pregnant women.
Patients not willing for trial |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in symptoms Yellowish discolouration of urine,Hematuria,Painful micturition,Burning micturition
Difficulty in micturition
Increased frequency of micturation
Normalization of urine pus cells count |
21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in frequency of attack of Pittaja Mutrakriccha |
31days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/08/2025 |
| 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 Yet Recruiting |
| 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
|
Urinary Tract Infections, which is stated in Modern Medicine, are comparable to Mutrakrichra. in lower UTI where dysuria, burning micturition and increased frequency of urination etc are most regular complaint. The clinical presentation of the Pittaj Mutrakrichra can be correlated to lower urinary tract infection.Ahara is mentioned as mahabhaishajyam.Pathya (therapeutic diet) plays a key role in the management of Diseases helping to reverse the pathology. Yogaratnakara explain paanakani topic in which he explained about Dhanya Paanaka and it is pitta and mutrakrichha hara .Yoga is both preventative and therapeutic, and it has been proved to improve the Body and mind in both physical and mental ways.One form of breath regulation involves inhalation through the mouth. That is sheetali (Chapter 2; Verse 57) [9]. Sheetali is commonly referred to as cooling pranayama.There are large numbers of individual research work being Carried out on Mutrakrichra and Ayurvedic Herbo minaral drugs but research regarding role of pathya kalpna and Pranayama is not available. The proposed research work is easy to practise, cost effective and convenient. So the clinical study will be conducted on diagnosed patients with Pittaja Mutrakriccha for period of 21days with the follow up after 10 days. Patients were divided into 2 groups. Each consisting of 100 patients. Group A will be treated with Gokshura churna, Group B with Dyanyapaanaka and Sheetali pranayama analysis symptoms will be done statistically on the basis of results obtained in objective and Subjective parameters Conclusion will be done on the analysis of Data obtained |