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CTRI Number  CTRI/2022/06/043269 [Registered on: 15/06/2022] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Open Label Randomized Clinical Trial]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To study the effect of Ayurvedic formulations on PramehajanyaTimira/Diabetic Macular Edema. 
Scientific Title of Study   A Randomized Clinical Trial to evaluate the efficacy of Khadirakramuka Kwath and Nishamlaki Per Orum with and without Nitya Virechana in the management of Pramehajanya Timira with special reference to Diabetic Macular Edema 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nivedita Sitpal 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room No. 314,Shalakya Tantra Department,National Institute Of Ayurveda Amer Road J.D.A. Market Brahampuri
Room No. 314,Shalakya Tantra Department,National Institute Of Ayurveda Amer Road J.D.A. Market Brahampuri
Jaipur
RAJASTHAN
302002
India 
Phone  09713523722  
Fax    
Email  sitpalnivedita777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gulab Chand Pamnani 
Designation  Associate Professor, Shalakya Tantra Department, National Institute of Ayurveda, Jaipur 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room No. 311,Shalakya Tantra Department,National Institute Of Ayurveda Amer Road J.D.A. Market Brahampuri
Room No. 311,Shalakya Tantra Department,National Institute Of Ayurveda Amer Road J.D.A. Market Brahampuri
Jaipur
RAJASTHAN
302002
India 
Phone  9461154942  
Fax    
Email  pamnani.gulab@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gulab Chand Pamnani 
Designation  Associate Professor, Shalakya Tantra Department, National Institute of Ayurveda, Jaipur 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room No. 311,Shalakya Tantra Department,National Institute Of Ayurveda Amer Road J.D.A. Market Brahampuri
Room No. 311,Shalakya Tantra Department,National Institute Of Ayurveda Amer Road J.D.A. Market Brahampuri
Jaipur
RAJASTHAN
302002
India 
Phone  9461154942  
Fax    
Email  pamnani.gulab@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar Singh Gate,Amer Road,Jaipur,Rajasthan (302002) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nivedita Sitpal  National Institute of Ayurveda  opd number 14, National Institute Of Ayurveda hospital building, Amer Road J.D.A. Market Brahampuri, jaipur
Jaipur
RAJASTHAN 		 09713523722

sitpalnivedita777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda (De- Novo),Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E133||Other specified diabetes mellituswith ophthalmic complications. Ayurveda Condition: Pramehajanya Timira,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: NISHAMLAKI, Reference: ASHTANG HRIDAY CHIKITSA STHAN 12/5, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: -
2Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charak chikitsa 13/61, Procedure details: Nitya Virechana with Erandabhrushta Haritaki 3 grams at bedtime with lukewarm water for 30 days)
(1) Medicine Name: Erandabhrushta Haritaki, Reference: Chakrapani,Chakradatt, chikitsa sthan 25/11 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Duration: 30 Days
3Intervention ArmDrugClassical(1) Medicine Name: Khadirkramuka kwath, Reference: SUSHRUTA CHIKITSA STHAN 11/9, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients between 40-70 years of age.
2. Diagnosed cases of Diabetes Mellitus Type 2.
3. NPDR cases with Macular Edema.
4. Clinically significant Diabetic Macular
Edema of less than 12 months duration.
5. Visual acuity minimum 6/60 or better.
6. Patients having HbA1c levels upto 8.
 
 
ExclusionCriteria 
Details  1. Hypertensive patients with systolic BP>160
and diastolic BP>95 mm Hg.
2. Patients having HbA1c levels greater than
8.
3. Diabetic patients with cardiovascular
problems.
4. History of ocular surgery within 4 months
prior to enrolment.
5. Pregnant diabetic patients.
6. Patients with moderate to severe
cataractous changes.
7. Patients having a history of glaucoma or
on-going treatment of glaucoma.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Central macular thickness Optical Coherence Tomography (OCT) in patients of DME.  At Baseline day and after completion of the trial

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in visual acuity in patients of DME.
2. Change in metamorphopsia (Amsler’s grid test findings) in patients of DME.
3. Change in colour vision in patients of DME.
 		 At Baseline day and after completion of the trial 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/06/2022 
Date of Study Completion (India) 31/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

NEED OF THE STUDY

The worldwide prevalence of diabetes mellitus (DM) has become a major concern to society which also affects the global public health and economy worldwide. Globally the number of people with DR will grow from 126.6 million in 2010 to 191.0 million in 20303. As India is becoming the Diabetic capital of the world, it possesses a severe challenge to policymakers in health care administration due to complications of the disease itself.

Blindness is one of the worst complications in the diabetic population and it accounts for 80% of blindness in DR due to Diabetic macular oedema (DME). Almost all the patients with Type I diabetes develop retinopathy in about 15 years. In those with Type 2 DM, the risk of DR increases with the duration of diabetes.

Whereas DME is more common in Type 2 DM. It has unique assessment criteria, since it can present in eyes at all levels of DR. Therefore, early screening and detection are crucial for arresting DME. Because the early damage is painless and unnoticed by the patient, regular screening of all individuals with diabetes is recommended.

In contemporary medical science, few treatment modalities are available like Laser Photocoagulation, Pars - Plana Vitrectomy (PPV) surgery, some pharmacotherapies like  intravitreal anti- vascular endothelial growth factor injections (anti VEGF injections ), intravitreal steroids etc. but, these therapies do not provide a satisfactory solution to the problem4. Hence, it is the need of the hour to establish a piece of scientific evidence that the Ayurvedic system of medicine has a safe, effective and economic approach that can decelerate the progression of the disease and the risk of vision loss.

DM can be correlated to Madhumeha which is a sub type of Prameha in Ayurveda. This disease has been greatly emphasized by our Acharyas as it causes major complications in other organs including the vision. Looking into the gravity of this problem, a new approach for effective control of this disease is sought which takes care of disease progression so that the patient’s sight can be preserved.

In the present scenario, DM and its complications (DR, DME) are related to unhealthy eating habits and lifestyle changes which are giving rise to the accumulation of unwanted toxins in micro channels of the body parts which affect the normal functioning of any organ including the eye. Hence, in the present study, Nitya Virechana is selected in diabetic patients for removing excessively accumulated toxins (Mala) at the tissue level and to correct Dhatvagni Mandya and Srotoavarodha in Siras especially related to eyes5. This therapy has Shothahara action also, which will correct the pathogenesis of DME. The drugs selected for oral administration have Chakshushya, Shothahara, and Pramehahara action.

AIM:

●       To evaluate the efficacy of Khadirakramuka Kwath and Nishamalaki tablet per orum with and without Nitya Virechana in the management of Diabetic Macular Edema W.S.R to Pramehajanya Timira.

OBJECTIVES:

1.     To study the concept of Timira, Prameha, their interaction and its resemblance with Diabetic Macular Edema.

2.     To evaluate the efficacy of Ayurvedic interventions on vision in patients of DME.

 

GROUPING OF PATIENTS:

In the present trial, 30 clinically diagnosed patients of Diabetic Macular Edema (Pramehajanya Timira) will be selected and randomly divided into two groups (15 patients in each group):

1)    Group A: 15 patients will be treated with oral administration of Khadirakramuka kwath and Nishamalaki tablets.

2)    Group B: 15 patients will be treated with Nitya Virechana with Erandabhrushta Haritaki and along with Oral administration of Khadirakramuka Kwath and Nishamalaki tablets.

ASSESSMENT CRITERIA:

Following parameters will be adopted for the assessment of the efficacy of the trial therapy:  

SUBJECTIVE PARAMETERS:

1.     Vihwal Drishti- Blurred vision

2.     Makshika Mashaka Kesha Jaala Pashyati- Floaters

3.     Tamasa Darshanam- Scotoma (black spots in front of eyes)

4.     Nasa Akshi Yuktani Vipritani Vikshate- distorted vision

5.     Photophobia

OBJECTIVE PARAMETERS:

1.     Visual acuity

2.     Best Corrected Visual Activity

3.     Pin hole test

4.     Colour Vision Test

5.     Amsler’s grid test

6.     Optical Coherence Tomography (OCT)- (Macular Thickness)

7.     Contrast Sensitivity Test (if available)

(Before and after completion of clinical trial)

 

 LAB INVESTIGATIONS:

1.     CBC

2.     RBS

3.     HbA1C

 

H0- There is no effect of Khadirakramuka Kwath and Nishamalaki tablets per orum used with Nitya Virechana and without Nitya Virechana in the management of Diabetic Macular Edema w.s.r Pramehajanya Timira.

References:

1.      Susruta,Susruta Samhita, chikitsa sthana 11/9, Ayurveda Tattva Sandipika, Hindi commentary by Kaviraja Ambikadutta Shastri, part I, Chaukhambha Sanskrit Sansthan, Varanasi, 2010,pg-76.

2.     Vagbhata, Astanga Hridya, chikitsa sthan 12/5 Nirmala Hindi commentary along with special deliberation by Dr. Brahmanda Tripathi, Chaukhamba Sanskrita Pratishthana, Delhi,2014.

3. Chakrapani,Chakradatt, chikitsa sthan 25/11 Vidyaprabha Hindi commentary by Dr. Indradev Tripathi , Chaukhambha Sanskrit Sansthan, Varanasi,2005,Pg-167. 
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