| CTRI Number |
CTRI/2020/08/027181 [Registered on: 17/08/2020] Trial Registered Prospectively |
| Last Modified On: |
12/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of indrayanadi churna with guda in the management of Bahupitta Kamala |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of indrayanadi churna with guda in the management of Bahupitta Kamala |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumant Andhale |
| Designation |
PG Scholar |
| Affiliation |
SST Ayurved Mahavidyalaya sangamner |
| Address |
At Pimplarui post chikhalbeed tq Wadwani Distric Bid maharashtra
SST Ayurved Mahavidyalaya, 2nd floor Kayachikista department
Nasik pune road ,opp prasad cafe ,Distric Ahmedanagar ,Sangamner Maharashtra 422605
Bid
MAHARASHTRA
431124
India |
| Phone |
8767819788 |
| Fax |
|
| Email |
sumantandhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr swati Soman |
| Designation |
Head of department |
| Affiliation |
SST Ayurved Mahavidyalaya Sangamner |
| Address |
Soman house,State Bank colony,Ganesh nagar ,Distric Ahmedanagar ,Sangamner Maharashtra 422605
SST Ayurved Mahavidyalaya,2nd floor kayachikista department
Nasik pune road ,opp prasad cafe ,Distric Ahmedanagar ,Sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9421438173 |
| Fax |
|
| Email |
Swati.soman68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr swati Soman |
| Designation |
Head of department |
| Affiliation |
SST Ayurved Mahavidyalaya Sangamner |
| Address |
Soman house, State bank colony Ganesh nagar ,Distric Ahmedanagar ,Sangamner Maharashtra 422605
SST Ayurved Mahavidyalaya 2nd floor kayachikista department
Nasik pune road ,opp prasad cafe ,Distric Ahmedanagar ,Sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9421438173 |
| Fax |
|
| Email |
Swati.soman68@gmail.com |
|
|
Source of Monetary or Material Support
|
| SST Ayurved Mahavidyalaya
Nasik pune road ,opp prasad cafe ,Distric Ahmedanagar ,Sangamner Maharashtra 422605 |
|
|
Primary Sponsor
|
| Name |
Dr sumant Andhale |
| Address |
At Pimplarui Post Chikhalbeed, Tq Wadwani ,Distric Beed, Maharashtra 431124 |
| 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 Sumant Andhale |
SST Ayurved Mahavidyalaya sangamner |
kayachikista OPD No 2 ground floor and Kayachikista IPD ward 2nd floor SST Ayurved Mahavidyalaya
Nasik pune road ,opp prasad cafe ,Distric Ahmedanagar ,Sangamner Maharashtra 422605
Ahmadnagar
MAHARASHTRA |
8767819788
sumantandhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B199||Unspecified viral hepatitis without hepatic coma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indrayanadi churna |
Indrayanadi churna containing indrayan and shunti with anupan Guda will be administered orally, Dose 1 gm after meal of morning and night ,Duration pf therapy 28 days |
| Comparator Agent |
Nishottar churna |
Nishottar churn with anupan Triphala churna will be administered orally ,Dose 2gm after mealof morning and night, Duration of therapy 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Bahupitta kamala
Serum bilirubin above 3 mg/dl |
|
| ExclusionCriteria |
| Details |
Known cases of Ruddhapatha kamala, kumbhakamala, Halimaka
ï‚· Serum Bilirubin more than 12mg /dl |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Indrayanadi churna with Guda is effective in the management of Bahupitta kamala |
Indrayanadi churna with Guda is effective in the management of Bahupitta kamala in 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nishottar churna with Triphala kwatha does not have or has less effective in the management of bahupitta kamala in 4 week |
Nishottar churna with Triphala kwatha has no or less singnificant improvement in sign and symptoms of bahupitta kamala
Outcome will be assessed daily from 0 day to day 28 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypothesis ÷ Indrayanadi churna with guda is effective in the management of Bahupitta kamala
Trial group Drugs ÷ Indrayanadi churna
Contents of Trial Drugs ÷ Indrayana ,Shunthi
Method of preparation÷ Indrayana and Shunthi taken in equal quantity and pounded seperately in fine powder and sieved then mixed together and mixture will be filtered by cotton cloth
Control group Drugs÷ Nishottar churna
Results ÷ Will be assessed maily on the basis of relief in sign and symptoms and level of serum bilirubin, patient will be taken in clinical trial from day 0 to day 28 |