| CTRI Number |
CTRI/2017/03/008088 [Registered on: 14/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF SHIGRU-HARIDRADI EYE DROP IN THE MANAGEMENT
ALLERGIC CONJUNCTIVITI |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL EVALUATION OF SHIGRU-HARIDRADI EYE DROP IN THE MANAGEMENT
NETRABHISHYANDA (ALLERGIC CONJUNCTIVITIS) |
| Trial Acronym |
SHED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VEDIKA SUBHASH ADE |
| Designation |
MS (AYU) SCHOLAR |
| Affiliation |
IPGT AND RA GUJARAT AUYURVED UNIVERSUTY JAMNAGAR GUJARAT |
| Address |
ROOM NO 218 PG GIRLS HOSTEL IPGT AND RA GUJARAT AUYURVED UNIVERSUTY JAMNAGAR
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
7698121149 |
| Fax |
|
| Email |
adevedika2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VEDIKA SUBHASH ADE |
| Designation |
MS (AYU) SCHOLAR |
| Affiliation |
IPGT AND RA GUJARAT AUYURVED UNIVERSUTY JAMNAGAR GUJARAT |
| Address |
ROOM NO 218 PG GIRLS HOSTEL IPGT AND RA GUJARAT AUYURVED UNIVERSUTY JAMNAGAR
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
7698121149 |
| Fax |
|
| Email |
adevedika2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANJUSHA RAJGOPALA |
| Designation |
PROFESSOR |
| Affiliation |
IPGT AND RA GUJARAT AUYURVED UNIVERSUTY JAMNAGAR GUJARAT |
| Address |
DEPATMENT OF SHALAKYATANTRA IPGT AND RA GUJARAT AUYURVED UNIVERSUTY JAMNAGAR
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA Gujarat ayurved University Jamnagar |
|
|
Primary Sponsor
|
| Name |
IPGT and RA Gujarat ayurved University Jamnagar |
| Address |
IPGT and RA Gujarat ayurved University Jamnagar |
| 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 D B Vaghela |
IPGT & RA Jamnagar Gujarat |
IPGT & RA GAU Jamnagar Gujarat
361008
Jamnagar
GUJARAT |
9825407899
drvaghela@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee ipgt ra jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
suffering from allergic conjectivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A |
Local Application: Shigru-Haridradi Eye Drop
(Combination of Shigru, Haridra, Daruharidra, Yastimadhu, Madhu)
Dose: 1 drop 4-6 times/day
Duration: for 6 weeks
|
| Intervention |
Group – B |
Local Application: Shigru-Haridradi Eye Drop
Dose: 1 drop 4-6 times/day
Duration: for 6 weeks
+
Oral: Arogyavardhini Rasa -250 mg
Khadira Churna- 2 gm
Rasayana churna -2gm
Haridra chruna -500 mg
1 Ẋ BD for 6 weeks
|
| Comparator Agent |
group c
|
Azelastin 0.05 % Eye Drop
Dose: 1 drop 2 times/day
Duration: for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with typical signs and symptoms of Netrabhishyanda (Allergic Conjunctivitis) are Vedana (pain), Kandu (itching), Lalima (redness), Prakashsangyata (photophobia), Guruta ( heaviness) and Srava (discharge). Pichchil Srava (mucus ropy secretion) Muhurmuhur Srava (repeated lacrimation) Guruta (heaviness of lids), Photophobia, Foreign body (FB) sensation, Burning sensation, Conjunctival congestion, |
|
| ExclusionCriteria |
| Details |
1. Patients having complications like corneal involvement like marginal corneal ulcer, dacryocyctites, trachoma, kerato conjunctivitis etc.
2. Patients below 10 years and above 35 years
3. Infective conjunctivitis
4. All types of Conjunctivitis (Acute & Chronic) which are non-allergic in nature are excluded from the Study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SHIGRU-HARIDRADI EYE DROPS cure NETRABHISHYANDA
ALLERGIC CONJUNCTIVITIS |
SHIGRU-HARIDRADI EYE DROPS cure NETRABHISHYANDA
ALLERGIC CONJUNCTIVITIS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SHIGRU-HARIDRADI EYE DROPS cure NETRABHISHYANDA
ALLERGIC CONJUNCTIVITIS and improve immunity of eye. |
HIGRU-HARIDRADI EYE DROPS cure NETRABHISHYANDA
(ALLERGIC CONJUNCTIVITIS) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
20/10/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Abhishyanda1 is one among the Sarvagata Netraroga causing great threat to the vision with mild to gross visual loss. According to Acharya Sushruta, Abhishyanda is the main cause for all the eye diseases and it is Aupasargikaroga. If not treated properly, it may lead to further complications like Adhimantha, Hatadimantha and Drustinasha. All the diseases of the eye can be produced by untreated Abhishyanda. The symptoms of Abhishyanda includes Syanda (tears),Vedana (pain), Raga (redness), Shoda (swelling), Gharsha (Foreign body sensation) itching (Kandu), redness (Lalima), photophobia (Prakashsangyata), heaviness ( Guruta ), and discharge ( Srava).2 Acharya Charaka states that when humors get provoked in the seats of the sense organs, they cause either the impairment or the irritation of the senses concerned3.
SHIGRU-HARIDRADI EYE DROPS used in MANAGEMENT OF NETRABHISHYANDA (ALLERGIC CONJUNCTIVITIS. in this study eye drop is manufacture in pharmacy of IPGT and RA Jamnagar. Atfer the the making of eye drop , drop packing in sterile container. Ayurvedic Eye Drops (alternative medicine) or ophthalmic preparation and oral medication which is devoid of side effects and can better manage the Allergic Conjunctivitis. In the management of Allergic Conjunctivitis most of the drugs are anti- allergic and immune-modulator is used. These two properties are present in oral medication. Many clinical studies suggest these drugs having anti-allergic property and improve immunity.7 Individual properties of oral medication are following-
1. Arogyavardhini Rasa: use in liver disorder, skin disease
2. Rasayana Churna:
a. Amalaki: Fruit possesses immune-modulatory properties.
b. Guduchi: The alcoholic and aqueous extracts of T. cordifolia have been tested successfully for adaptogenic and immuno-modulatory activity.
c. Gokshura: Gokshura having hepatoprotective and diuretic property.Khadira: Hepatoprotective.
4. Haridra : Anti-AllergicClinical study:
For clinical study, patients attending the O.P.D. of the Department of Shalakya Tantra of I.P.G.T&R.A Hospital, Jamnagar would be selected randomly irrespective of age, sex, habit, religion etc. Selected patient will be studied in three groups, Group A, Group B and Group C. Patients information sheet shall be prepared and the patient’s information consent shall be taken before starting the treatment. Any adverse drug reaction observed during the treatment shall be managed accordingly and noted.INVESTIGATIONS:
1. Biochemical tests, routine hematological, will be carried out before study to rule out any systemic diseases.
2. Absolute eosinophil count will be carried out before and after study.
3. Peripheral conjunctival smear examination will be carried out before and after treatment.
GROUPING: Selected Patients will be randomly assigned into two groups-
Group- A, Group –B, Group-C
Group – A: Local Application: Shigru-Haridradi Eye Drop
(Combination of Shigru, Haridra, Daruharidra, Yastimadhu, Madhu)
Dose: 1 drop 4-6 times/day
Duration: for 6 weeksGroup – B: Local Application: Shigru-Haridradi Eye Drop
Dose: 1 drop 4-6 times/day
Duration: for 6 weeks
+
Oral: Arogyavardhini Rasa -250 mg
Khadira Churna- 2 gm
Rasayana churna -2gm
Haridra chruna -500 mg
1 Ẋ BD for 6 weeks
Group – C: Azelastin 0.05 % Eye Drop
Dose: 1 drop 2 times/day
Duration: for 6 weeks
Treatment Period: for 6 weeks
Follow Up: A minimum period of one month was planned for the follow up study.
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