| CTRI Number |
CTRI/2021/08/035781 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of productive cough with help of Vanafsha decoction and Identification of different types of Vanafsha. |
|
Scientific Title of Study
|
Identification of different species used as Vanafsha and To evaluate the clinical efficacy of Viola pilosa Blume in Kaphaj Kaas. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navneet Sharma |
| Designation |
Reader |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Tehsil Baijnath
Disttt. Kangra
H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418080689 |
| Fax |
|
| Email |
dr.navneetsharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navneet Sharma |
| Designation |
Reader |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Tehsil Baijnath
Disttt. Kangra
H.P.
HIMACHAL PRADESH
176115
India |
| Phone |
9418080689 |
| Fax |
|
| Email |
dr.navneetsharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Laxmi Mehra |
| Designation |
PG Student |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Tehsil Baijnath
Disttt. Kangra
H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9129997999 |
| Fax |
|
| Email |
divyamehrasp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy,RGGPG Ayurvedic College and Hospital, Paprola, District Kangra, H.P.
Research Institute in I.S.M. Joginder Nagar, Distt. Mandi, H.P. |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Tehsil Baijnath, Distt. Kangra, H.P. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department of Dravyaguna, RGGPG Ayurvedic College and Hospital, Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navneet Sharma |
R G G P G Ayurvedic Hospital, Paprola |
OPD number 209, RGGPG Ayurvedic Hospital, Paprola, Tehsil Baijnath,
Kangra
HIMACHAL PRADESH |
9418080689
dr.navneetsharma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: kaphaj kaas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
vanafsha kwaath for internal use |
30 patients wiil be given vanafsha kwaath for inernal use for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing for trial
2. Age - 18-70 years
3. Sex - Either sex
4. Diagnosis - on the basis of following symptoms (as per classical texts):
1. Shweta shleshma pravartan(White phlegm)
2. Uroruk (Chest pain)
3. Shiroruja (Headache)
4. Peenas (Watery nasal discharge)
5. Arochak (Loss of appetite)
6. Gourav (Feeling of heaviness)
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for trial.
2. Known case of Pulmonary tuberculosis.
3. Known case of any major chest pathology
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| overall improvement which will be shown by the patients in sign and symptoms according to subjective and objective criteria. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| general feeling of well being |
7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| Date of Study Completion (India) |
04/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
30 patients will be given the interventional drug: Vanafsha kwaath. Criteria of assessment is kept on the basis of relief in the sign and symptoms of the disease Kaphaj Kaas. All the patients will be examined after three days of treatment and completion of trial. |