| CTRI Number |
CTRI/2020/03/023810 [Registered on: 06/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| 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
|
Study of Yavaksharadi Guti And Khadiradi Guti in Tundikeri(Tonsillitis). |
|
Scientific Title of Study
|
A Standard Controlled Clinical Study On Yavaksharadi Guti And Khadiradi Guti In The Management Of Tundikeri. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tushar Laxman Rupanawar |
| Designation |
PG student BAMS MD |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9421600275 |
| Fax |
|
| Email |
drtusharrupnwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
HOD Kaumarbhritya |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tushar Laxman Rupanawar |
| Designation |
PG student BAMS MD |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9421600275 |
| Fax |
|
| Email |
drtusharrupnwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College Of Ayurved And Research Centre Akurdi PUNE Nigdi Pradhikaran Sector 25 |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi Pune |
| Address |
Nigdi Pradhikaran sec.no 25 Akurdi Pune |
| Type of Sponsor |
Private 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 Tushar Rupanawar |
Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi |
Vitthal Rukmini road,
Sector No 27, Nigdi
Pradhikaran, pune
411044, Name of
OPD-Kaumarbhritya,
OPD No. 118, Ground
floor, Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9421600275
drtusharrupnwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Khadiradi Guti |
Khadiradi Guti is prepared by Gutikalpana and will be given orally after meal twice a day with Madhu which includes follow up on every 3rd, 5th and 7th day |
| Intervention |
Yavakshardi guti |
Yavakshardi guti is prepared by Gutikalpana and will be given orally after meal twice a day with Madhu which includes follow up on every 3rd, 5th and 7th day |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with two or more symptoms like Kathin Shotha, Todvat vedna, Ragatwa, Asyavairasya, Galoparodha as described in the context of Tundikeri.
2 Children of both genders.
3 Age group – 6 - 12 yrs.
|
|
| ExclusionCriteria |
| Details |
Patients with peritonsilar abscess,tonsilar cyst, Tonsillolith will be excluded.
Patients with k/c/o HIV, TB. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Yavakshardi guti as per weight twice a day with Madhu is as effective as Khadiradi guti as per weight twice a day with Madhu in Tundikeri for 7 days. |
To evaluate efficacy of Yavakshardi guti as per weight twice a day with Madhu is as effective as Khadiradi guti as per weight twice a day with Madhu in Tundikeri for 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study The Side Effects of Drug If Any. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2020 |
| 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="0"
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)?
|
|
Brief Summary
|
tonsil are active and first line of defence during childhood.Here is a great need of effective conservative management without surgical procedure. Tundikeri is a
highly prevalent disease in the age group of 5-15 years.Tundikeri can be
correlated with Tonsillitis which presents features like Kathina shotha
(enlargement of tonsils), resembling Karpasaphala (fruit of cotton), Toda
(pain), Ragatwa (redness), Galoparodha (dysphagia), and Asyavairasya (distaste
in mouth). It is one of the most prevalent diseases in
children, during first decade of life, incidences 7% of all visits to the
pediatricians.childrens are more suffering with this disease. |