| CTRI Number |
CTRI/2021/04/032744 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate The Addon Effect Of Ghrita Guggul Sikthasya Dhumpan With Vyoshadi Vati In Allergic Rhinitis. |
|
Scientific Title of Study
|
A Standard Controlled Clinical Trial To Evaluate The Addon Effect Of Ghrita Guggul Sikthasya Dhumpan With Vyoshadi Vati In Allergic Rhinitis. |
| Trial Acronym |
RIGIDITY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indrayani Narendra Nakshane |
| Designation |
PG 1st Year |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
Ayurved Rugnalaya & Sterling Multispeciality Hospital, Sector No 27, Nigdi
Pradhikaran, Pune
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi
Pradhikaran, Pimpri Chinchwad, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8482817906 |
| Fax |
|
| Email |
nakshaneindrayani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor And HOD of Shalakyatantra |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
Ayurved Rugnalaya & Sterling Multispeciality Hospital, Sector No 27, Nigdi
Pradhikaran, Pune
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi
Pradhikaran, Pimpri Chinchwad, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor And HOD of Shalakyatantra |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
Ayurved Rugnalaya & Sterling Multispeciality Hospital, Sector No 27, Nigdi
Pradhikaran, Pune
PDEAS College of Ayurved and Research Center, Sector No 25, Nigdi
Pradhikaran, Pimpri Chinchwad, Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved & Research Centre Sector no. 25 Pradhikaran Nigdi PCMC Pune |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Center |
| Address |
ctor No 25, Nigdi
Pradhikaran, Pimpri Chinchwad, Pune - 411044 |
| 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 Indrayani Narendra Nakshane |
PDEAs Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi Pradhikaran Pune |
Vitthal Rakhumai Road, Sector No 27, Shalakya Tantra OPD No. 122, Nigdi
Pradhikaran, Pune – 411044
Pune
MAHARASHTRA |
8482817906
nakshaneindrayani@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:J309||Allergic rhinitis, unspecified. Ayurveda Condition: ALLERGIC RHINITIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ghrita Guggul Sikthasya Dhumpan With Vyoshadi Vati |
Group A 30 Patients will be treated with Vyoshadi Vati 250mg, 2 tablets vyanodane (after lunch, after dinner) for 21days with Ghrita Guggul Sikthasya Dhumpan for 7days in two settings with gap of 7days in between |
| Comparator Agent |
Vyoshadi Vati |
Group B 30 patients will be treated with Vyoshadi Vati 250mg, 2 tablets vyanodane (after lunch, after dinner) for 21days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients from age group of 18 to 50 years irrespective of gender, religion, occupation having signs and symptoms of Allergic rhinitis -
1. Recurrent Sneezing
2. Watery Rhinorrhoea
3. Nasal Obstruction |
|
| ExclusionCriteria |
| Details |
1. Known cases of chronic non-specific infective rhinitis like
hypertrophic rhinitis, rhinitis sicca, rhinitis caseosa, atrophic rhinitis,
malignant granuloma
2. Patients with Tumors, malignancy of any kind.
3. Pregnant women.
4. Patients having sign and symptoms of Covid-19 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Addon Effect Of Ghrita Guggul Sikthasya Dhumpan To Vyoshadi Vati In Allergic Rhinitis. |
21 Days with follow up on 8th, 15th, 22nd day and 1 month after completion of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effect of the drug, if any |
21 Days with follow up on 8th, 15th, 22nd day and 1 month after completion of the treatment |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Allergic rhinitis is very common disease in day to day life, increase in pollution, food habits, lifestyle leads to allergic condition to chronic stage. In India 20% to 30 % population is suffering from allergic rhinitis. It is characterized by spasmodic attack of severe sneezing, rhinorrhoea and nasal obstruction. Symptoms of Allergic rhinitis are similar to those of Kshawathu disease described in Ayurveda. Treatment for allergic rhinitis in modern science is anti-histamines and steroids, given orally and also through nasal route, but their drugs only give symptomatic effect and are not free from adverse effect. And hence recovery of symptoms leads to chronicity of disease.As Vyoshadi vati is proven to be moderate to highly
effective in Allergic rhinitis according to previous studies. Ghrita Guggul
Sikthasya Dhumpanis taken for study to check if it can increase the efficacy
Vyoshadi vati in Allergic rhinitis when given together.
|