| CTRI Number |
CTRI/2021/04/032626 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
06/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Drakshadi Yog and Pippali Churna in Kasa in children |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to evaluate the efficacy between Drakshadi Yog and Pippali Churna in the management of Kasa in children belonging to the age group of 3 to 12 years. |
| Trial Acronym |
KASA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuja Pradiprao Ghadage |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Center, Nigdi, Pune. |
| Address |
PDEAs College of Ayurved and Research Center , 3rd floor, Kaumarbhritya Department, Sector no. 25, Pradhikaran, Nigdi, Pune
Pune
Maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9404997121 |
| Fax |
|
| Email |
anujaghadage1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
H.O.D of Kaumarbhritya Department |
| Affiliation |
PDEAs College of Ayurved and Research Center, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Center, 3rd Floor, Kaumarbhritya Department, Sector No. 25, Pradhikaran, Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Pradiprao Ghadage |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Center, Nigdi, Pune. |
| Address |
PDEAs College of Ayurved and Research Center, 3rd floor, Kaumarbhritya, Department, Sector No. 25, Pradhikaran, Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9404997121 |
| Fax |
|
| Email |
anujaghadage1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Center, Sector No. 25, Pradhikaran, Nigdi, Pune. |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Center Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Center, Sector No.25, Pradhikaran, Nigdi, 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 Anuja Pradiprao Ghadage |
Ayurved Rugnalay and Sterling Multispeciality Hospital Nigdi, Pune |
Balrog OPD no. 118 ground floor, Sector 27 ,Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA |
9404997121
anujaghadage1994@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:J988||Other specified respiratory disorders. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drakshadi Yog |
Group A will be treated with Drakshadi Yog containing Draksha, Pippali, Suntha, Madhu, Goghrita.
Drakshadi Yog will be given orally according to clarks formula thrice a day for 7 days in the age group of 3 to 12 years which includes followup on 3rd and 7th day. |
| Comparator Agent |
Pippali churna
|
Group B will be treated with Pippali churna and madhu orally according to clarks formula thrice a day for 7 days in the age group of 3 to 12 years which includes followup on 3rd and 7th day. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of both sex belonging to age group 3 to 12 years.
Patient presenting with classical symptoms of kasa due to any cause except exclusion criteria.
Those have not received any medicine for last 24 hours.
Non COVID patients. |
|
| ExclusionCriteria |
| Details |
Patients presenting with symptoms of Tamakshwas, Kshtajkasa, Kshayajkasa.
Patients suffering from any associated life threatening disease including aspiration syndrome, emphysema, pneumothorax, pneumonia bronchial asthma, pulmonary tuberculosis.
Any congenital anomaly related to respiratory or cardiovascular system.
Known cases of any chronic infection should be excluded like HIV, Cancer. |
|
|
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 compare the efficacy of Drakshadi Yog thrice a day with Pippali Churna with madhu in Kasa in children. |
7 days with followup on 3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of Drakshadi Yog and Pippali Churna if any. |
7 days with followup on 3rd and 7th 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
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2021 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Since Kapha is main culprit in production of Kasa and Kapha is dominating dosha in balyavastha. Kasa is one of the most frequently encountered problem in balyavastha. Early intervention is necessary in case of Kasa as it is poetntial nidanarthakara vyadhi to produce Kshaya. Also, presently drug used in treatment of cough gives temporary relief but further have significant side effects. So there is need to treat and improve patients by using safe, palatable and effective medicine for Kasa in Pediatric age group. Drakshadi Yog is indicated in shishunam Kasa and having Kaphavatahara property Hence selected to assess the action of drug in Kasa in children . |