| CTRI Number |
CTRI/2025/07/090911 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
clinical study to evaluate effect of shunthyadi kwath in mutrashmari w.s.r to urolithiasis |
|
Scientific Title of Study
|
An open randomised controlled clinical trial to evaluate efficacy of shunthyadi kwath in mutrashmari w.s.r to urolithiasis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Dilip Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
R.A.Podar govt.ayurvedic college Worli mumbai |
| Address |
OPD No.10 Shalyatantra Department,M.A.Podar Hospital,R.A.Podar
Govt(Ayu) collage,Worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9850836496 |
| Fax |
|
| Email |
rohugaikwad97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidya Murlidhar Jangle |
| Designation |
Assistant professor |
| Affiliation |
R.A.podar govt. ayurved college Worli mumbai |
| Address |
OPD No.10 Shalyatantra Department,M.A.Podar Hospital,R.A.Podar
Govt(Ayu) collage,Worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8698681417 |
| Fax |
|
| Email |
vidyajangle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidya Murlidhar Jangle |
| Designation |
Assistant professor |
| Affiliation |
R.A.podar govt. ayurved college Worli mumbai |
| Address |
OPD No.10 Shalyatantra Department,M.A.Podar Hospital,R.A.Podar
Govt(Ayu) collage,Worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8698681417 |
| Fax |
|
| Email |
vidyajangle@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.10 Shalyatantra Department,M.A.Podar Hospital,R.A.Podar
Govt(Ayu) collage,Worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
|
|
Primary Sponsor
|
| Name |
R.A.govt.(ayu)college Worli mumbai 400018 |
| Address |
R.A.podar govt. ayurvedic college Worli Mumbai 400018 Dr. Anne Besant road PIN code -400018 |
| Type of Sponsor |
Government medical college |
|
|
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 Rohit Dilip Gaikwad |
Mahadevi Anandi Lal Podar govt. hospitall |
OPD No.10 Shalyatantra Department,M.A.Podar Hospital,R.A.Podar
Govt(Ayu) collage,Worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India
Mumbai
MAHARASHTRA |
9850836496
rohugaikwad97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of institution RA Podar govt ayu college worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: MUTRASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Kwath, Reference: Sushrut sutrasthan 33/4, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi kwath, Reference: Bhaishajya ratnavali vol 2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi kwath, Reference: Bhaishajya ratnavali vol 2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varunadi kwath, Reference: Bhaishajya ratnavali vol 2, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of either sex.
2. Age between 20 - 60 yrs.
3. Patient of Mutrashmariwith USG evidence of single calculus/multiple calculi of 4 mm to max 10 mm.
4. Patient of Mutrashmari with renal, uretric, and UVJ calculus. |
|
| ExclusionCriteria |
| Details |
1. Patients of obstructive pathology with changes of severe hydronephrosis in USG.
2. Patient is having uncontrolled diabetes, Asthma and other major systemic illness.
3. Impaired renal function.
4. Pregnant and lactating mother.
5. Urinary calculi having size more than 10 mm.
6. Kshar ayogya vyadhi like Jwara, Raktapitta, Urahkshat, Murchha, UTI. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of Shunthyadikwath with Varunadikwath in the management of Mutrashmari.
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out whether this drug reduces the size of Mutrashmari or promotes its expulsion.
2. To find out its effect on the symptoms of Mutrashmarilike burning micturition,pain hematuria etc.
|
45 days |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
01/08/2025 |
| 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 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
|
Ayurveda being the ancient science of healing has described the diseases of urinary track under three main headings that is Mutrakriccha, Mutraghata and Mutrashmari. Of them Mutrashmari being one of the commonest anomalies in present era. Acharya Sushruta the father of surgery has described comprehnsively about Mutrashmari, its etiology, symptomology, pathology, classification, complications and management Acharya Sushruta has included Ashmari in Ashtomahagadi one of the eight troublesome disease and Ashmari is kaphapradhan tridoshaj vyadhi . In modern science the disease can be correlated with Urolithiasis. Urolithiasis is one of the commonest problems around the globe and the incidence of calculi differs as per age, sex and geographical distribution, Urolithiasis reached to its peak in population aged above 30 yrs, the male to female ration is 0.9 and overall recurrence rate in male to female is 2 as to one Before proceeding to surgical procedure like Lithotripsy firstly we should try to manage with oral medication.
Need of study In modern era there are many techniques like open surgery, cytolithotomy, ureterolithotomy available for treating urolithiasis. Most of these techniques are expensive and costly limiting to higher economy class people. All these procedures can remove formed stone but do not break the samprapti which brings the formation of stones. Hence therefore it is very necessary to findout an alternate, inexpensive, safe and effective therapy affordable to people of all economic class. In Bhaisajya ratnavali mentioned about the usage of Shunthyadi kwath helpful for removing Mutrashmari as it contains all the ingredients having Katu, Tikta and MadhurRasa, Katuvipaka and Ushnaveerya and it is Bhedana in Karma, the Shunthyadi kwath ingredients is easily available The procedure of preparation of Shunthyadi kwath is very simple as there is need to evaluate an alternative and safe effective therapy for mutrashmari, reachable for people of all economic class
Number of patients Group A Study group 25 patients will be administered shunthyadi kwath Group B Control group 25 patients will receive Varunadi kwath Investigations
USG Abdomen and pelvis X-RAY KUB URINE Routine and microscopic CBC BSL KFT
CONCLUSION AND SUMMARY On the basis of available literature, observation and discussion will be precisely drawn and whole dissertation will be summarized.
FINAL OUTCOME
1 Decrease in size of stone 2 Improvement in symptom like pain and micturition.
|