To study the effect of Ayurvedic formulations on PramehajanyaTimira/Diabetic Macular Edema.

Phase 2

Completed

• Conditions: Other specified diabetes mellituswith ophthalmic complications. Ayurveda Condition: Pramehajanya Timira,

• Registration Number: CTRI/2022/06/043269
• Lead Sponsor: National Institute of Ayurveda

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:**

â—       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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Study Completion: 2023-07-31
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Central macular thickness Optical Coherence Tomography (OCT) in patients of DME.	At Baseline day and after completion of the trial

Secondary Outcome Measures

Name	Time	Method
1.Changes in visual acuity in patients of DME.	2.Change in metamorphopsia (Amsler’s grid test findings) in patients of DME.

Trial Locations

Locations (1)

National Institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Nivedita Sitpal

Principal investigator

09713523722

sitpalnivedita777@gmail.com