| CTRI Number |
CTRI/2019/01/016923 [Registered on: 04/01/2019] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effect of haritaki sunthi guda on ajirna |
|
Scientific Title of Study
|
Inter-relationship of Hetu and Lakshana in context to ‘Eko Hetu Anekasya’- A survey and clinical study |
| Trial Acronym |
hleha |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharmik R Vasani |
| Designation |
MD Scholar |
| Affiliation |
IPGT and RA |
| Address |
3rd Floor Department of Basic Principles IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7984216763 |
| Fax |
|
| Email |
dharmikvasani46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh Vyas |
| Designation |
Associate Professor |
| Affiliation |
IPGT and RA |
| Address |
3rd Floor Department of Basic Principles IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433231 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitesh Vyas |
| Designation |
Associate Professor |
| Affiliation |
IPGT and RA |
| Address |
3rd Floor Department of Basic Principles IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433231 |
| Fax |
|
| Email |
drhavyas@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
IPGT and RA GAU Jamnagar Gujarat India 361008 |
| 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 |
| Dharmik R Vasani |
IPGT and RA Hospital |
OPD No 11 Department of Basic Principles IPGT and RA Hospital Jamnagar
Jamnagar
GUJARAT |
7984216763
dharmikvasani46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC IPGT and RA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haritaki Sunthi Guda vatika |
Kalpana Vati
Dose 2 Vati of 500 mg each two times/ day
Route of administration Oral
Time of administration After meal
Anupana warm water
Duration 15 day
|
| Comparator Agent |
Placebo Rosted suji |
Kalpana Capsule
Dose 2 Capsule of 500 mg each two times/day
Route of administration Oral
Time of administration After meal
Anupana warm water
Duration 15 day
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be selected on the basis of classical signs and symptoms of Ajirna i.e. Ajirna symptoms in (cha.chi.15/45-46) like Vishtambha, Sadana, Shiro ruk, Jrumbha, Bhram, Jwara, Chhardi, Arochak, Avipak |
|
| ExclusionCriteria |
| Details |
Patients below 20 to above 60 years of age will be excluded.
Patients suffering from chronic major illness Like D.M. and contra indication for Haritaki will also excluded like (Ruksha, Krusha, Kshudhita,Trusna.(cha.chi.1/1(35))
Patient suffering from chronic major G.I. track disorder like Ulcerative Colitis, G.E.R.D., Cholera, Dysentery, Celiac Disease and Diverticulitis will also excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical subsidence in the sign and symptoms of Ajirna.
Improvement in the associated symptoms will be assessed by scoring and gradation pattern.
Status of Agni will be assessed before and after the treatment.
Thus obtained data will be assessed statistically and presented along with explanatory notes, discussion and conclusion
|
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical subsidence in the sign and symptoms of Ajirna.
Improvement in the associated symptoms will be assessed by scoring and gradation pattern.
Status of Agni will be assessed before and after the treatment.
Thus obtained data will be assessed statistically and presented along with explanatory notes, discussion and conclusion
|
15 Days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A clinical study was carried out to
evaluate effect of Haritaki+Sunthi+Guda
on symptoms of Ajirna. Total sixty patients were registered for clinical
study. All those patients were randomly divided into two groups. In Group A – subjects were
treated with Haritaki+Sunthi+Guda vatika, while Group B
– subjects were treated with placebo (Rosted suji) capsule. v
Comparison between two
groups In chief complain & associate complain: Statistically
significant difference was found in Gourava, Aruchi, Avipaka and Vibandh
while statistically insignificant difference was found in complain like Anila
Mudhata and Vistambha. (Table 6.41) Statistically significant
difference was found in Sadhyobhukta Udgar while statistically
insignificant difference was found in complain like Shiroshoola, Amlodgar and
Daha. (Table 6.44) v Comparison between two groups in Abhyavarana
Shakti & Jarana Shakti: While
doing comparison between two groups in Abhyavarana Shakti, Statistically
significant difference was found in Quantity of food, Frequency of food,
Intensity of hunger and Duration between Two meals. (Table 6.47) And
comparison between two groups in Jarana Shakti, Statistically
significant difference was found in Vegotsarga, Laghuta, Utsaha, Udgar
Shuddhi, Klama Parigaman, Kshudha. (Table 6.50) v ALL
OVER RESULT OF THE TREATMENT: (Table 6.51)
After completion of the clinical
trial in group A, 86.66% of the patients had moderate improvement while 13.33%
of the patients had mild improvement. Whereas in group B, 46.66% of the
patients had mild improvements while 53.33% of the patients had un- changed. In
this study total 60 patients were completed the treatment protocol among them
43.33% of the patients had moderate improvement, 30% of the patients had mild
improvement and 26.66% of the patients had Unchanged after treatment. |