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CTRI Number  CTRI/2018/01/011476 [Registered on: 22/01/2018] Trial Registered Prospectively
Last Modified On: 23/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   STUDY OF AYURVEDIC MANAGEMENT OF NEPHROTIC SYNDROME 
Scientific Title of Study   EVALUATION OF MULTI-PHASIC OPTIMIZED AYURVEDIC MANAGEMENT IN THE PATIENTS OF PRIMARY NEPHROTIC SYNDROME 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikas C Patel 
Designation  PG Scholar 
Affiliation  J S Ayurveda college, Nadiad. 
Address  B/4, Kailashdham Society, B/H Purusottam nagar, Old Dumral Road, Nadiad. (387002) Dist.-Kheda. Gujarat.
J S Ayurveda college, collage road, Nadiad. (387001) Dist- Kheda. Gujarat.
Kheda
GUJARAT
387002
India 
Phone  9586582481  
Fax    
Email  drvikaspatel912@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S N Gupta 
Designation  MD(Ayu) Professor & HOD kayachikitsa department 
Affiliation  J S Ayurveda college Nadiad 
Address  J S Ayurveda college, collage road, Nadiad. (387001) Dist- Kheda.

Kheda
GUJARAT
387001
India 
Phone  9825261305  
Fax    
Email  guptayurveda@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vikas C Patel 
Designation  PG Scholar 
Affiliation  J S Ayurveda college, Nadiad. 
Address  B/4, Kailashdham Society, B/H Purusottam nagar, Old Dumral Road, Nadiad. (387002) Dist.-Kheda. Gujarat.
J S Ayurveda college, collage road, Nadiad. (387001) Dist- Kheda. Gujarat.
Kheda
GUJARAT
387002
India 
Phone  9586582481  
Fax    
Email  drvikaspatel912@gmail.com  
 
Source of Monetary or Material Support  
J S Ayurveda college and P D Patel Ayurvedic Hospital, college road, Nadiad-387001 
 
Primary Sponsor  
Name  J S Ayurveda college  
Address  J S Ayurveda college, college Road, Nadiad. (387001) Dist-Kheda. Gujarat. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vikas C Patel  P D Patel Ayurveda Hospital  Kayachikitsa department, Room 204, Nadiad.(387001) Kheda, Gujarat.
Kheda
GUJARAT 		 9586582481
9586582481
drvikaspatel912@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Primary Nephrotic syndrome patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurvedic classical herbal formulation  1.Vardhamana pippali rasayana kalpa: Fine powder of pippali (Piper longum Linn.) will be given in increasing and tapering dose-pattern. 2.Virecana karma: Mridu virecana (purgation) will be performed with the help of eraṇḍa sneha (oil of the seeds of Ricinus communis Linn.). Oral Medications: 3.Gokshuradi guggulu – 3 tablets (each of 300 mg) 3 times in a day after food with warm water 4.Shuddha Shilajita – 5gm 2 times in a day with milk. 5.Haritakyadi kvatha – 40 ml 2 times in a day after food. 6.Rasayana churna – 3 gm 3 times in a day with water. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient who have confirmed diagnosis of Primary type of nephrotic syndrome (idiopathic) of both the genders and between 18 to 50 years of age group. 
 
ExclusionCriteria 
Details  1. Patients of nephrotic syndrome due to other disorders i.e SLE, Henoch Schonlein purpura, amyloidosis and infection with HIV, parvovirus B19 and hepatitis B and C viruses, Diabetes mellitus, Drug toxicity, any genetic disorders etc.
2. Patients having complication of nephrotic syndrome like CRF etc.
3. Patients who associated with some serious illness i.e. tuberculosis, cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, Cushing’s syndrome, thromboembolic disorders etc.
4. Patients with an eGFR (glomerular filtration rate) less than 60 ml/min/1.73m2.
5. Female patients having pregnancy, lactating or post-delivery period.
6. Patients of nephrotic syndrome who are contraindicated for virecana. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Ayurvedic management in the patient of primary Nephrotic syndrome.  Grade score of sign and symptoms along with laboratory investigation before treatment and after treatment of 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   N/A 
Date of First Enrollment (India)   24/01/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable.This thesis work will yet to be submit. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Evaluation the effectiveness of the Ayurvedic treatment in the patients of primary nephrotic syndrome is the main objective of study.Patients who fulfill the diagnostic and inclusive criteria (mentioned below) will be selected irrespective of demographic division from out-patient department (OPD) and in-patient department (IPD) of J S Ayurveda College and P D Patel Ayurveda Hospital, Nadiad. And then they will be treated with following treatment.

Phase – 1 (first 13 days period):

Vardhamana pippali rasayana kalpa: Fine powder of pippali(Piper longum Linn.) will be given in increasing and tapering dose-pattern. In this pattern 1 g powder of Piper longum will be given twice with honey on the first day. Every day the dose will be increased by 1 g eventually to reach to 5 g twice daily. The dose of 5 g will be kept for 5 days and then tapered down 1 g every day to finally reach 1 g again. This will take 13 days.

Phase – 2 (14th to 16th day period):

Virecana karma: On the 14th day mridu virecana (purgation) will be performed in the patients with the help of eranda sneha (oil of the seeds of Ricinus communis Linn.). The dose of eranda sneha will be 30 to 40 ml according to the patient’s koshtha(frequency and sensitivity of bowels). All the patients will be kept on the samsarjana krama (rest period with special diet) for next two days.

Phase – 3 (17 th to 28 th day period):  

After the completion of purgation, following treatment will be given orally for next 12 days.

1.              1.      Gokshuradi guggulu (Gokshura + Guggulu + Haritaki + Bibhitaki + Amalaki + Sunthi + Maricha + Musta)– 3 tablets (each of 300 mg) 3 times in a day after food with warm water.

2.      Shuddha Shilajita– 5gm 2 times in a day with milk.

3.      Haritakydi kvatha (Haritaki + Duralabha + Aragvadha + Gokshura + Pashanabheda)– 40 ml 2 times in a day after food.

4.      Rasayana churna (Gokshura + Amalaki + Guduchi)– 3 gm 3 times in a day with water.

Follow up - The patient will be instructed to come for a follow up on every 2 weeks for next 1 month. During follow-up period, all the patients will be instructed to take the oral medicaments except pippali as per the schedule at home along with pathyapathya. 

 

 
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