| CTRI Number |
CTRI/2022/12/048174 [Registered on: 16/12/2022] Trial Registered Prospectively |
| Last Modified On: |
14/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two formulations Haritkyadi Paryoga and Kampilak Tail Nasya in management of Nasagata Raktapitta w.s.r to Recurrent Epistaxis |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Haritkyadi Paryoga and Kampilak Tail Nasya in the management of Nasagata Raktapitta w.s.r to Recurrent Epistaxis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
Reader , P.G Deptt. of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola |
| Address |
Department of Shalakya Tantra , Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Himachal Pradesh
Department of Shalakya Tantra
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
Reader , P.G Deptt. of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola |
| Address |
Department of Shalakya Tantra , Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Himachal Pradesh
Department of Shalakya Tantra
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Thakur |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola |
| Address |
Department of Shalakya Tantra Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Himachal Pradesh
Department of Shalakya Tantra Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8091172839 |
| Fax |
|
| Email |
tshilpi116@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1. Charak Pharmacy, RGGGPG Ayurvedic College And Hospital Paprola , Distt Kangra, H.P
2. Research Institute in I.S.M Jogindernagar , Distt Mandi , H.P
3.Baijnath Pharmacy |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola , Distt Kangra ,Pin Code - 176115 , H.P |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijayant Bhardwaj |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola |
OPD No. 201 Rajiv Gandhi Government Post Graduate Ayurvedic Hospital Block, Paprola ,Distt Kangra H.P
Kangra
HIMACHAL PRADESH |
9418017568
bhardwajvijayant@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Humman) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: NASAGATA-RAKTAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritkyadi Paryoga, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak Samhita, Procedure details: Procedure details: 2 bindu in each nostri 2 hourly. In emergency, if patient will present with active bleeding,then nasal packing will be done with kampilak tail. and after removal of nasal packing,Kampilak Tail nasya will be given.)
)
(1) Medicine Name: Kampilak Tail, Reference: Chakradat, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: qid, Duration: 2 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with active epistaxis and/or with history of epistaxis.
Patients having any systemic disease i.e. hypertension, liver disease, kidney disease etc.
Patients who consented to participate. |
|
| ExclusionCriteria |
| Details |
Congenital deformity.
Pregnant patients.
Patients not willing to be registered for the trial. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms in patients of epistaxis. |
Relief in symptoms in patients of epistaxis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of Haritkyadi Prayoga and Kampilak Tail Nasya in improvements in nose bleeding of patients. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/12/2022 |
| 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="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients will be selected from OPD / IPD of RGGPG Ayurvedic College and hospital Paprola. 3 groups of 30 patients will be registered as assessed to evaluate the effect of Kampilak Tail Nasya And Haritkyadi Paryoga in the management of Nasagata Raktapita w.s.r to Recurrent Epistaxis. |