| CTRI Number |
CTRI/2024/03/064026 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of Kalyanaka kshara and Vidangadi Gutika along with Shwadanshtradi kwath after Koshtha Shodhana in the Management of Mutrashmari (Urolithiasis) |
|
Scientific Title of Study
|
A Comparative Clinical study to evaluate the efficacy of Kalyanaka kshara and Vidangadi Gutika along with Shwadanshtradi kwath after Koshtha Shodhana in the Management of Mutrashmari (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 |
Vidhi Jain |
| Designation |
Post Graduate Resident |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
C Block, 6th Floor,Room No. 618 Department Of Kayachikitsa , All India Istitute Of Ayurveda, Sarita Vihar , New Delhi
South
DELHI
110076
India |
| Phone |
9868386792 |
| Fax |
|
| Email |
vdvidhijainaiia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Proff. Dr. Jonah Sandrepogu |
| Designation |
Head Of Departement |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
C-Block, 6th Floor Room No. 617,Department Of Kayachikitsa, All India Institute Of Ayurveda ,Mathura Road, Gautampuri, Sarita Vihar
South
DELHI
110076
India |
| Phone |
9448262298 |
| Fax |
|
| Email |
jonahdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Proff. Dr. Jonah Sandrepogu |
| Designation |
Head Of Department |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
C-Block, 6th Floor, Room No. 617 ,Department Of Kayachikitsa, All India Institute Of Ayurveda ,Mathura Road, Gautampuri, Sarita Vihar
South
DELHI
110076
India |
| Phone |
9448262298 |
| Fax |
|
| Email |
jonahdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda ,Mathura Road, Gautampuri, Sarita Vihar , New delhi-110076
|
| 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 Vidhi Jain |
All India Institute Of Ayurveda |
C-Block, 6th Floor,Room No.618 ,Department Of Kayachikitsa, All India Institute Of Ayurveda ,Mathura Road, Gautampuri, Sarita Vihar
South
DELHI |
9868386792
vdvidhijainaiia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division Of Translational Research And Biostatistics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N20-N23||Urolithiasis. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kalyanaka khasra, Reference: Ashtang Hridaya chikitsa sthan 8/140-143, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Go Ghrita), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Gutika, Reference: Abhinava Chintamani 37 kiran/ 12-13, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Kidney stone size up to 10 mm and/or
2. Ureteric Stone size up to 8 mm and/or
3. Urinary Bladder Stone size up to 10 mm.
4. Radiographic and /or USG evidence of the stone. |
|
| ExclusionCriteria |
| Details |
1. Chronic Renal failure.
2. Gross Hydronephrosis.
3. Cases which require surgical intervention.
4. Severe Hematuria.
5. Kidney stone and Bladder Stone size more than 10 mm.
6. Ureteric stone Size more than 8 mm
7. Known cases of Malignancy, Tuberculosis.
8. Known cases of HIV (Human Immunodeficiency Virus), VDRL (Venereal Disease Research Laboratory) and
Hepatitis-B positive.
9. Patients with HbA1C ≥ 9 And Grade 3 hypertension: SBP greater than or equal to 180mmHg and/or DBP
greater than or equal to 110mmHg.
10. Patients with previously known allergy of any of the interventional drugs or ingredients.
11. Patients not willing for trial and follow up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 80% Reduction In The Symptoms Of Mutrashmari |
0th Day , 14th Day ,28th Day , 43rd Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction In The Size Of Stone |
0th Day AND 43rd Day |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="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
|
Patient suffering from HTN, DM, asthma, and anaesthetic drugs sensitivity etc needs some alternative management to
avoid surgical procedures. These factors invite the need of an effective medicinal treatment for urolithiasis with least
chances of recurrence.
Though different Aachaaryas have been described use of various medicines along with the Kshaara Dravyas, Kwathas,
Ras aushadhis, etc. No work is done on the concept of Koshtha shodhana followed by Shwadanshtradi kwath ( RefBhaishajya ratnavali ashmari chikitsa) with Kalyanaka kshara and with Vidangadi Gutika. Also, usage of Kalyanaka
Kshara(as mentioned in its Phal shruti in Ashtanga Hridaya Arsha chikitsa) in Mutrashmari is not explored. Vidangadi
Gutika mentioned in “Abhinava Chintamani – Ashmari Chikitsaâ€
vii is undertaken in this research study as it is an
unexplored formulation. In the study kshara was selected due to its multiple properties Chedana (Excision), Bhedana
(Incision), Lekhana (Scraping), Shodhana (Cleaning), Ropana (Healing) etc. |