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CTRI Number  CTRI/2012/05/002639 [Registered on: 10/05/2012] Trial Registered Retrospectively
Last Modified On: 23/04/2012
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 Dry Eyes 
Scientific Title of Study   Clinical Evaluation of Maha Triphaladya Ghrita in the Management of Dry Eye Syndrome (Shushkakshipaka) 
Trial Acronym  ACT- DES-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; and 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  
Name  Address 
NIL   
 
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 Dr A Shareef Ahamed   Government Ayurveda College, Thiruvananthapuram  Department of Shalakya, Thiruvananthapuram-695001, Kerala, India
Thiruvananthapuram
KERALA 		 9446479059
0471-2473656
drsubhadrapotty@yahoo.com 
Prof K S Dhiman Dr Rajesh Gadhiya   Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar  Department of Shalakya, Gujarat Ayurved University, Jamnagar-361001, Gujarat, India
Jamnagar
GUJARAT 		 9723821965
0288-2676856
dr_ks_dhiman@yahoo.co.in 
Dr Nalini C Dr Ashwini B N   Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan  Department of Shalakya, Thannirohalla, B.M. Road, P.B. No.-64, Hassan-573201
Hassan
KARNATAKA 		 9449719756
08172-256464
drnalinicg@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IInstitutional Ethics Committee, Govt. Ayurveda College, Trivendrum, Kerala, India.  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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dry Eye Syndrome,  
 
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 containg 450 ml Duration of therapy-12 weeks 
Intervention  Maha Triphaladya Ghrita  Dose – 20 ml once a day Dosage form - Ghrita Route of Administration –Topical Time of Administration-once a day Duration of therapy-12 weeks 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged between 35 to 70 years.
2. Patients presenting with signs and symptoms of Dry eye syndrome.
 Schirmer-I test positive i.e. < 10 mm.
 Tear film break-up time less than 10 seconds.
 Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on the cornea.
(If Any two of the above three criteria are present; the diagnosis of Dry Eye Syndrome is confirmed)
3. Willing and able to participate in the study for 16 weeks. 
 
ExclusionCriteria 
Details  1. Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.
2. Inflammatory conditions like acute conjunctivitis etc.
3. Systemic diseases causing Dry Eye Syndrome.
4. 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.
5. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
6. Women who are pregnant or lactating
7. Patients on steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study
8. Smokers/Alcoholics and/or drug abusers
9. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
10. Patients with evidence of malignancy
11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
12. H/o hypersensitivity to the trial drug or any of its ingredients.
13. Patients who have completed participation in any other clinical trial during the past six (06) months.
14. Any other condition which the Principal Investigator 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 
1.Change in the Clinical Parameters.  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 
1. Change in the Tear Film break up time
2. Change in Schirmer I Test
3. Change in Rose Bengal Staining. 		 At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   23/12/2010 
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   To be published after the completion of 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  

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.

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 Dry Eye Syndrome 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.

Similar clinical trial, being carried out as an Intra Mural Research (IMR) activity by CCRAS in its peripheral institutes has been registered with the Clinical Trials Registry, India (CTRI/2012/03/002532). The collective evidence generated during the A.C.T. project as well as the I.M.R. program would scientifically substantiate the clinical effect of the Mahatriphaladya Ghrita in the patients suffering from Dry Eye Syndrome.

 
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