| CTRI Number |
CTRI/2012/01/002375 [Registered on: 25/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of an Ayurvedic formulation in the treatment of Conjunctivitis. |
|
Scientific Title of Study
|
Clinical Evaluation of Mahatriphaladya Ghrita in the Management of Allergic Conjunctivitis. |
| Trial Acronym |
ACT- AC-2010 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (co-ordinator ACT project) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri-110058
West
DELHI
110058
India |
| Phone |
011-28525831 |
| Fax |
011-28520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Support in terms of infrastructural facilities:
1. Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar.
2. Government Ayurveda College, Thiruvananthapuram.
3. Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan. |
|
|
Primary Sponsor
|
| Name |
Department of AYUSH Ministry of Health Family Welfare Government of India |
| Address |
Department of AYUSH, Ministry of Health & Family Welfare,
Government of India, IRCS Building, Red Cross Road, New
Delhi-110001. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSubhadra Antharjanam DrCMJimin |
Government Ayurveda College, Thiruvananthapuram |
Department of Shalakya, Thiruvananthapuram-695001
Thiruvananthapuram
KERALA |
9446479059
0471-2473656
drsubhadrapotty@yahoo.com |
| DrManjusha R DrSadhana Parajuli |
Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar |
Department of Shalakya, Gujarat Ayurved University, Jamnagar-361001
Jamnagar
GUJARAT |
9428400759
0288-2676856
bhatrajma2008@gmail.com |
| DrAshwini MJ DrElsy Lukose |
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan |
Department of Shalakya, Thannirohalla, B.M. Road, P.B. No.-64, Hassan-573201
Hassan
KARNATAKA |
9448222694
08172-256464
drashwinidhanapal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IInstitutional Ethics Committee, Govt. Ayurveda College, Trivendrum. |
Approved |
| Institutional Ethics Committee, IPGT&RA, Jamnagar, Gujarat, India |
Approved |
| Institutional Ethics Committee, SDM College of Ayurveda, Hassan, Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Allergic Conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maha Triphaladya Ghrita |
Dose – 15 ml twice daily
Dosage form - Ghee
Route of Administration – oral
Time of Administration-Twice a day before food
Anupana-Lukewarm Water
Packing form-Plastic jar/bottle containg 450 ml
Duration of therapy-12 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged between 16-35years.
2. Patients presenting with signs and symptoms of Allergic Conjunctivitis.
3. Willing and able to participate for 16 weeks. |
|
| ExclusionCriteria |
| Details |
1. Patients having complications like marginal corneal ulcer, dacryocystitis, trachoma, kerato - conjunctivitis, Infective conjunctivitis, etc.
2. Patients having genetic predisposition to allergy.
3. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
6. Pregnant / lactating females
7. Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
8. Smokers/Alcoholics and/or drug abusers
9. Patients with evidence of malignancy
10. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
11. H/o hypersensitivity to the trial drug or any of its ingredients.
12. Patients who have completed participation in any other clinical trial during the past six (06) months.
13. Any other condition which the P.I. thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
|  Symptomatic improvement. |
At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
To be published after the completion of the clinical trials in all the three centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country. This present clinical trial on Allergic Conjunctivitis is one of these eighteen clinical trials. Mahatriphaladya Ghrita is a medicated semisolid poly-herbal formulation containing Haritaki (Terminalia chebula), Bibhitaki (Terminalia belerica), Amlaki (Emblica officinalis), Bhrngaraja (Eclipta alba), Vasa (Adhatoda vasica), Satavari (Asparagus racemosus), Guduci (Tinospora cordifolia), Pippali (Piper longum), Draksa (Vitis vinifera), Utpala (Nymphaea stellata), Madhuka (Glycyrrhiza glabra), Kantakari (Solanum xanthocarpum), Ksira kakoli (Fritillaria roylei), Aja kshira (goat milk) and Goghrta. The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of Mahatriphaladya Ghrita - a classical Ayurvedic formulation. This formulation has been in use since ages and found to be useful in treating Allergic Conjunctivitis and promoting the health. The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project. |