| CTRI Number |
CTRI/2016/02/006670 [Registered on: 22/02/2016] Trial Registered Prospectively |
| Last Modified On: |
20/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Nagaradi decoction on digestive capacity |
|
Scientific Title of Study
|
A critical study on Shama Prakopau Doshanam Sarvesham Agni Samshritau wsr to Grahanidosha and its management with Nagaradi kashaya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zaibfatima R Vakil |
| Designation |
MD Scholar |
| Affiliation |
IPGT and RA |
| Address |
OPD No 18 Department of Basic Principles IPGT and RA GAU
Jammagar OPD No 18 Department of Basic Principles IPGT and RA
GAU
Jamnagar
GUJARAT
368001
India |
| Phone |
9426314488 |
| Fax |
|
| Email |
zaibvakil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Baghel |
| Designation |
Associate proffesor |
| Affiliation |
IPGT and RA |
| Address |
OPD No 18 Department of Basic Principles IPGT and RA GAU
Jammagar OPD No 18 Department of Basic Principles IPGT and RA
GAU Jammagar
Jamnagar
GUJARAT
368001
India |
| Phone |
9426433575 |
| Fax |
|
| Email |
asbaghel@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof M K Vyas |
| Designation |
Professor HOD |
| Affiliation |
IPGT RA |
| Address |
OPD No 18 Department of Basic Principles IPGT and RA GAU
Jammagar OPD No 18 Department of Basic Principles IPGT and RA
GAU
Jamnagar
GUJARAT
368001
India |
| Phone |
9426953118 |
| Fax |
|
| Email |
drmaheshvyas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGT RA GAU Jamnagar Gujarat India |
|
|
Primary Sponsor
|
| Name |
IPGT RA GAU Jamnagar Gujarat |
| Address |
IPGT RA GAU Jamnagar Gujarat India 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Zaibfatima Vakil |
IPGT and RA Hospital |
opd no 18 ipgt and ra
hospital gujarat
ayurveda university
Jamnagar
Jamnagar
GUJARAT |
9426314488
zaibvakil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Grahanidosha, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nagaradi Kashaya |
40 ml
Niranna kala twice a day
15 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The patients having classical signs and symptoms of Grahanidosha viz. Abaddha Mala-Pravritti and Sashleshma Mala-Pravritti, Sushka Varcha, Aam Varcha, Adhmana, Arochaka, Udargaurav, Parshvaruja etc. |
|
| ExclusionCriteria |
| Details |
Worm infestation
Patients suffering from acute and chronic disease like Ulcerative colitis, Gastric and Peptic ulcer etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.
Objective: Change in investigations |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.
Objective: Change in investigations |
15 days |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/02/2016 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is open label clinical study to evaluate the effect of Nagaradi Kashaya om Grahanidosha as well as on Agni and Doshavastha. PLAN OF STUDY The study will be carried out in two parts. · Conceptual study · Clinical study CONCEPTUAL STUDY Materials and Methods:. All the available authentic classical texts of Ayurveda, viz. Samhitas, Samgraha, Granthas and their respective commentaries and texts written by eminent of scholars of modern era, latest journals, research papers, periodicals, articles, minutes of seminars, medical literature, available material on internet will be referred keenly to explore the subject. The compiled material will be critically analyzed and evaluated to form the conceptual base of study. CLINICAL STUDY Materials and Method: A detailed and precised proforma will be designed to evaluate the effect of Nagaradi Kashaya on Jatharagni and on the state of Doshas in Grahanidosha. The drug selected for the study will be assessed clinically after taking the proper consent of patient. SELECTION CRITERIA: · The patients having classical signs and symptoms of Grahanidosha viz. Abaddha Mala-Pravritti and Sashleshma Mala-Pravritti, Sushka Varcha, Aam Varcha, Adhmana, Arochaka, Udargaurav, Parshvaruja etc. will be selected. · Patients will be selected from the age group of 16-40 years, irrespective of sex, religion and caste etc. EXCLUSION CRITERIA: · Age group of less than 16 years and more than 40 years · Worm infestation · Patients suffering from acute and chronic disease like Ulcerative colitis, Gastric and Peptic ulcer etc. INVESTIGATIONS: Following investigations will be carried out to rule out any other pathology: 1. Complete blood count : 2. Urine : Routine and microscopic examinations. 3. Stool : Routine and microscopic examinations. DRUGS AND GROUPING: Study design: Interventional No. of patients: 30 Name of drug : Nagaradi Kashaya (Ch.Chi. 15/98) Ingredients: | Dravya | Latin name | Part used | Proportion | | Nagara | Zingiber officinale Roxb. | Rhizome | 1 part | | Musta | Cyperus rotundus Linn. | Rhizome | 1 part | | Ativisha | Aconitum heterophyllum Wall. | Root | 1 part | Form : Kashaya (decoction) Dose : 40 ml twice a day Sevankala : Niranna Kala Duration : 2 weeks CRITERIA FOR ASSESSMENT: Subjective: Improvement in classical symptoms of Grahanidosha. Objective: Change in investigations Data generated during the above study will be presented in systemic manner and will be analyzed by paired t test. Collected, compiled and analyzed data will be presented with proper discussion and an attempt will be made to give concrete conclusion. |