Management of changes in eye due to diabetes mellitus
- Conditions
- Patients diagnosed of diabetic retinopathy fulfilling inclusion criteria
- Registration Number
- CTRI/2016/04/006803
- Lead Sponsor
- Institute for post graduate teaching and research in ayurveda gujrat ayurved university
- Brief Summary
The frame of the present research work entitled **Effect of *Ayurvedic* Treatment protocol in themanagement of *Madhumehajanya* *Timira* w.s.r. to DiabeticRetinopathy-A Clinical Study**hasbeen disposed into following sections:
1. Introduction
2. Conceptualstudy-Ayurvedic & Modern review
3. Drugreview- Pharmacognostical &Analytical Study
4. Procedurereview
5. Clinicalstudy
6. Discussion
7. Summaryand Conclusion
**1) Introduction:**
In Introduction part,the gravity and incidence of the disease has been discussed. Its hypothesis in *Ayurvedic*literature regarding concept of the disease, treatment and selection of therapyafter reviewing the previous research works done has been explained thoroughly.The plan of study with the selected aims and objectives was also given in briefin this portion. Hypothesis regarding selection of procedures was made upon thefacts that in *Madhumeha*, there is *Rakta* vitiation due to *Kleda*and *Kapha Vargiya Dravyas* causing damage to *Rasayanis.* Laterthere will bederangement *of Kapha* causing *Pitta Dushti*and further leads to a condition similar to *Raktapitta.* Based upon thishypothesis *Koshtashodhana* was adopted. *Takradhara* which checksbleeding, acts on relieving stress and nourishes the *Shira Marma* wasadopted along with *Nasya* which is having sense organ stimulant, *Srotoshodhaka*and *Raktapittahara* properties. *Rasayana Yoga* was consistingof all *Pramehahara* and *Chakshushya* drugs and was selected on thebasis ofhypothesis that it affects both *Madhumehameha* as well as*Madhumehajanya Timira.*
**Aimsand objectives**
1. Tounderstand *Madhumehajanya Timira* inthe light of Diabetic Retinopathy – various ocular complications of Diabetesmellitus.
2. Toevaluate the clinical efficacy of the adopted treatment approach in DiabeticRetinopathy
**Hypothesis**
**Null Hypothesis** (**H0**)
The adoptedAyurvedic treatment is not effective in managing Diabetic Retinopathy.
**Alternative Hypothesis** (**H1**)
The adoptedAyurvedic treatment is effective in managing Diabetic Retinopathy.
**2) ConceptualStudy:**
**a) Ayurvedicreview**
*MadhumehajanyaTimira* is a *Drishtigata Roga*. The term *Drishti* hasbeen used bothfunctionally and structurally in our classics. After acomprehensive review regarding this term, it has been concluded that eyeball asa whole along with structures directly involved in visual process starting withtear film, central cornea, lens, retina as a whole and optic tract can be takenas *Drishti* with selectivity as percontexts. In *Prameha Pidika, Rasayani Daurbalya* concept has come whichoccurs due to *Kleda and Kapha Bahulya* as well as due to *Apana* and*Vyana Vayu Dushti* in the body due toimproper/no treatment of *Prameha*and continuation of etiological factors. Also another fact that *Rasayani Daurbalya*is present since the starting phase of the disease but manifested as fundusfindings later and visual symptoms still later came into consideration whilereviewing the literature.
On comparing the etiological factors a greatsimilarity between etiological factors of *Prameha* as well as *Netra Rogaswere found*. Moreover *medievalperiod book*, *Netraprakashika* hasa direct reference of *Netra Rogas* due to *Prameha.* By taking allthese concepts the study was planned. The modern review of the disease wastaken from different text books, peer review journals and internet. Thepathogenesis involved in is *Rasayani Daurbalya* (vascular damageconsisting endothelial cell damage, pericyte loss etc.) was analysed in both *Ayurvedic*and Modern perspectives.
**b) Modern Review**
As the major structureevident to be involved in Diabetic retinopathy is Retina, due importance hasbeen given to retina and its anatomy has been dealt with in detail. In diseasereview, detailed description regarding etiology, pathogenesis, classificationand treatment have been dealt.
**3) Drug Review:**
Drug review deals with the detailed description of selected formulations i.e. Drugs of *Takradhara, Durvadi Ghrita* which was used for *Marsa* and*Pratimarsha Nasya* and *Rasayana Yoga* and the logic/ reasonbehind the selection of formulations.
Under Drug Review,Pharmacognostical as well as Analytical study of the drugs were given in detailwith their main physico- chemical parameters.
**4) Procedure Review:**
Procedure review introduces the detailed descriptionof selected procedures i.e *Koshtashodhana Karma, Shirashodhana, Takradhara, Marsa*and *Pratimarsha Nasya* for thepresent clinical study.
**5) Clinical Study:**
Clinical study section deals with the need and planof study in detail, aims and objectives, material and methods, criteria forselection of patients in the study and exclusion criteria, Grouping, treatmentschedule, assessment criteria and observations in tabular form along with thestatistical analysis of results obtained.
1. **Thestudy was approved by Institutional ethics committee letter no. PGT/7A/Ethics/2015-16/2625 dated 11/12/15.**
2. **TheClinical trial was registered under CTRI with CTRI No. CTRI/2016/04/006803registered on 07/04/2016.**
AClinical Research Proforma was designed consisting of examination of thepatient, various investigations etc. Based on the assessment criteria andobservations, the effects and results of the therapy were assessed. Thepatients were selected by SIMPLE RANDOM SAMPLING METHOD & were divided into2 groups:
**GroupA: (Trial Group) – 70 patients**
**GroupB :( Control Group) – 30 patients**
The study was conducted in black box design.
InclusionCriteria
Ø Patientswilling for the treatment.
Ø Patientsof 30-70 years having Type 2(Non insulin dependent) diabetes with or withoutvisual disturbances, but with detectable ophthalmoscopic features of DR.
Ø Patientof Type 2(Non insulin dependent) diabetes with blood sugar level, FBS- 126 to220 mg/dl or PPBS-180 to 300 mg/dl with ongoing treatment.
ExclusionCriteria
Ø Patientswho are extremely debilitating and those who are not able to withstandtreatment procedures.
Ø Patientsof Type-1 Diabetes or the patients of Type-2 Diabetes taking Insulin.
Ø HighRisk DR or those requiring emergency intervention.
Ø Patientsof DR with media opacities like cataract, vitreous degeneration etc. whichinterfere with ophthalmoscopical findings.
Ø Patientshaving other ocular pathologies like glaucoma, high myopia etc.
Ø HypertensiveRetinopathy and DR associated with pregnancy.
Ø Patientswhose BCVA is less than 6/60
A total of 100 patientsdiagnosed to have diabeticretinopathy with symptoms and/or signs wereselected for the study. 10 patients dropped out were later excluded from thestudy. The selected patients were assigned randomly into two groups (A &B),group A having 62 and group B having 28 patients. Each group was subjected tothe treatment in the following method.
**STUDY DESIGN(GROUPING):**
**Group A:(Treatment Group)**
**Preparatory Stage:**
1) *Deepana Pachana* with *ShivaksharaPachana Churna*/ *Chitrakadi Vati/* *AmapachanaVati/ Trikatu Churna* 5-10 gms/ 1 tablet with lukewarm water orally twice daily for 5-7 days according to the *Koshta*of patients.
2) *KoshtaShodhana* with *ErandaBrishta Hareetaki/ Avipattikara Churna -*5-10gms with lukewarm water orally in morning for 3-5 days according to the *Koshta*and *Prakriti* ofpatients.
3) *Shirashodhana*with *Anu* *Taila*– 8-10 drops into each nostril for 7 days.
**Treatment phase**:
1)*MarshaNasya with Durvadi Ghrita-*8-10 drops into each nostril for 7 days followedby *Pratimarsha Nasya* with same. Total three sitting of *Marsha Nasya*was done.
2) *Takradhara*by *Siddha-Takra* as medium 30 minutesdaily for 15 days in morning. Total three sitting of *Takradhara* was done.
3) Oral Medication *(Anubhuta Rasayana Yoga) -* 3 gmat bed timewith 3gm *Madhu* and 6 gm *Ghrita.*
**Allthe above therapies were continued along with Anti-hyperglycemic treatment asadvised by the treating physician.**
**GroupB: (Control Group)**
Diagnosed cases of DM having DR changes were includedand kept under observation till the whole therapy period. They were continuedwith their anti-hyperglycemic and anti-DR treatment, if any.
**Durationof Therapy and Follow up:**
The therapy was continued for 90 days.
Follow up study was done for 1 month at 15 daysinterval.
Theeffect of treatment was assessed on the basis of both subjective criteria andobjective criteria; since the improvements in both patients’ vision andophthalmoscopic features are necessary in Diabetic Retinopathy to say if theexisting stage of retinopathy regressed or maintained. Specialized scoring pattern for subjective criteriawas adopted. Whereas for objective assessment of therapy Best Corrected Visualacuity, Ophthalmoscopy, Fundus photography, Fundus Fluorescein Angiography and Opticalcoherence tomography was adopted. Laboratoryinvestigations - FBS, PPBS, HbA1C, S. Cholesterol, Hb, S.G.O.T, S.G.P.T, Urea, S.Creatinineand Urine sugar were also taken for assessment.Results were assessed in terms of percentage relief andstatistical evaluations.
**Observations (Demographic data)**
Maximum number ofpatients was of age group between 61-70years. Majority of the patients weremale i.e. 57(57.00%) and rest patients were female i.e. 43(43.00%). Majority ofpatients were Hindus i.e. 94(94.00%) and 06(06.00%) patients were Muslim. Majorityi.e. 98 (98.00 %) patients were married. 38(38.00%) patients were house wivesfollowed by 25(25.00 %) patients retired. Maximum patients (51.00%) were uneducated.Majority of the patients i.e. 47.00% belonged to middle class. In this study100.00% belonged to *Jangala Desha.* Maximum (91.00%) of patients wereVegetarian. Maximum i.e. 84.00% patients were having good appetite. Maximum82.00% patients were having sound sleep. Itwas observed that 64.00% were having *Mridu Koshta.*Maximum (92.00%) patients were having normal micturition. It wasobserved that 11.00% patients were addicted to Tobacco. It was observed that84.00% of patients had moderate built. Maximum female patients, i.e 86.04 %were in menopausal period. It was observed that 86.00% were using spectacles. In*Aharaja Nidana*, 20.00% were having excessive use of curd. In *Viharaja Nidana*, 15.00% patients were having mental stress and 15.00 %patients were having daysleeping. Maximum i.e. 66.00% of patients were taking *Madhura Rasa* dominantdiet. Also 55.00% of patients were taking *Snigdha Guna* dominant diet.
It was observed that 63.00%patients were of *Pittakapha Prakriti,* 37.00 % patients were of *Rajasik Prakriti*, 95.00% patients werehaving *Madhyama Satva,* 93.00% patients were found to have *Madhyama Sara,*95.00 % of patients were having *Madhyama* *Samhanana,* 95.00% ofpatients were having *Madhyama* *Pramana,* 95.00% were having *Madhyama**Satmya,* 94.00 % of patients were having *Madhyama* *Ahara Shakti,*92.00 % of patients were having moderate exercises, 61.00% were in the *Madhyama* age group and 95.00% patients were having *MadhyamaVikruti*.
**Observations on Disease.**
All (100.00%) of patientswere having complaints of diminished vision, followed by 18.00 % of patientshaving complaints of blurriness of vision. No patients had complaints offrequent changes in presbyopic glasses, perception of flashes of light,floaters and problem for dark adaptation. In this study 95.00% of patients had NPDR, 05.00% had PDR and 04.00%had DME. Majority of patients 73.00% were having dot blot haemorrhages.Superficial Haemorrhages were seen in 49.00 % patients. 60.00% patients werehaving hard exudates. In the study, 96.00% patients had gradual onset of ocularcomplaints and 04.00% had sudden onset. In the study 63.00 % were having chronicityof 0-1 year whereas 30.00 % patients were having chronicity of 2 –5 years. Maximumnumber of the patients, i.e.48.00% was having history of Diabetes up to 5years. 27.00 %reported onset of Diabetes 6-10 years ago. It was observed that 97.00%patients were having regular control of Blood sugar level. Positive family history was reported in23.00% and 77.00% had no family history of DM. Also 41.00 % were foundto be hypertensive.
A detailed description of effect of therapy wasgiven on the basis of subjective criteria, objective parameters and labinvestigations. In brief the comparative results of both the groups can beexplained like this-
**a) Comparative Effects in both Groups**
**On Symptoms-** Onsymptoms like defective vision and blurred vision, both the groups hadstatistically insignificant result.
**On Signs-**Treatmenton Group A was more effective in reducing dot-blot haemorrhages, superficialhaemorrhages, hard exudates and BCVA.
**On Lab Parameters-** onlab investigations like FBS and S. Cholesterol, Group A was better than Group Bwhereas on PPBS, Hb, HbA1C and urine sugar both the groups were showing more orless same results which was statistically insignificant. It could also beconcluded that there was no statistically significant change in SGOT, SGPT,Urea and S. creatinine in Trial group. Thus there was no change in liverfunction and renal function tests in patients of trial group after taking *Rasayana yoga*.
**b) OverallEffect of Therapy**
· In Group A, out of 62 patients, 04(06.45%) got moderate improvement after the completion of treatment, 23(37.09%)got mild improvement, 35 (56.45%) remained unchanged. No eye showedprogression.
- In Group B, out of 28 patients, 02 (07.14%) got moderate improvement after the completion of treatment, 06 (21.42%) got mild improvement, 18 (64.28 %) remained unchanged and 02(7.14 %) showed worsening in condition.
- Thus it may be concluded that Group A where Ayurvedic treatment were also given with modern-counterpart showed over all better effect.
6)**Discussion:**
A detailed discussionwas done on selection of disease, conceptual part, and selection of proceduresand drug with their probable modes of action, clinical study and effect oftherapy on all the selected patients. Some important discussion on results are-
• Group A (TreatmentGroup) was effective in reducing dot blot haemorrhages and superficialhaemorrhages. This can be said that Group A indicates towards improving healthof retinal vasculature in this short duration of treatment with a significantimprovement in hemorrhages by reducing the *Kleda*in blood and improving the other *Dushyas*,and by virtue of *Rasayana Yoga, Takradhara* and *Nasya* the*Rasayani daurbalya* is countered,thereby the structural health ofthe body vasculature is strengthened. That’s why no fresh haemorrhage wasobserved.
• Group A was more effective in lowering FBS andS.cholesterol showing that integrated approach in DM gives a better FBS andS.cholesterol control. It is reflecting that treatment by *Takradhara,Pratimarsha Nasya* and *Rasayana* therapy after *Koshtashodhana* ingroup A was helpful in blood sugar and S. cholesterolcontrol along withits maintenance for a long period.
• There was no statistically significantchange in SGOT, SGPT, Urea and S. creatinine in Trial group. Thus there was nochange in liver function and renal function tests in patients of trial groupafter taking *Rasayana Yoga*.
*Koshtashodhana* byvirtue of its *Kledaharana*, *Pitta Shodhana*, *Rakta Prasadana* actions;*Sirasodhana* due to its *Urdhwasrota Shodhana* effect; *Durvadi GhritaMarsa and Pratimarshanasya* by its *Rakta Sthambhaka* and senseorganrejuvenating properties, *Takradhara* due to its *Raktha Sthambhaka, Kledaharana,Sophaharana* and mental relaxant effect and all drugs used in *Rasayanayoga* by their *Chakshushya* and *Pramehahara* properties havetheir role in combatingthe pathogenesis of *Madhumehajanya Timira*DR. Thus by these virtues the holistic *Ayurvedic* approach is helpful ingiving a complimentary treatment protocol to the DRpatients.
**Secondary outcome of the study:** Allpatients reported betterment in their physicaland mental well beingwhich suggests that Holistic approach is improving the Quality of life andvision. Some reported attainment of good sleep following *Takradhara* which verifies its soothing and mental relaxing effect.
**Adverse reactions**:No adverse reactions were reported in any of the patients duringtheentire study period and follow up
**CONCLUSION**
From the present study following **conclusions**are drawn:
• Group A (Treatment Group) showed betterresults on Dot blot haemorrhages, Superficial haemorrhages, hard Exudates,BCVA, FBS and S. cholesterol.
• Boththe groups showed almost similar effects in PPBS, Hb , HbA1C and urine sugarwhich was statistically insignificant.
• Therewas no statistically significant change in SGOT, SGPT, Urea and S. creatininein Trial group showing the safety of *Anubhuta**Rasayana Yoga*.
• Therewas no statistically significant change in symptoms like defective vision andblurred vision in both groups.
The better results in the treatment group(Group A)may be due to the improved health status of whole body vasculature speciallymicrovasculature in retina i.e *Rasayanis*, which prevented furtherexudations thereby decreasing retinal oedemaleading to improved visual status.Hence the null hypothesis was rejected and alternate hypothesis ie,†Theadopted *Ayurvedic* treatment is effective in managing DiabeticRetinopathy†has been proved.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Patients willing for treatment Patients having type 1 and type 2 (non insulin depandent) with or without visual disturbances,but the detectable ophthalmoscopic features of DR Patients of type 1 and type 2 (non insulin dependent) with blood sugar level,FBS-126 to 220 mg/dl or PPBS-186 To 300 mg/dl with ongoing treatment.
- Patients who are extremely debilitating and those who are not able to withstand treatment procedures Patients of type-1diabetes or type-2diabetes taking insulin High risk DR Or those requiring emergency intervention Patients of DR witg media opacity like cataract, vitreous degeneration etc.
- Which interfere with ophthalmoscopical finding Patients having other ocular pathologies like glaucoma high myopia etc Hypertensive retinopathy and DR Associated with pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method signs and symptoms of DR will improve with treatment 90 days
- Secondary Outcome Measures
Name Time Method blurring of vision will improve 90days
Trial Locations
- Locations (1)
O.p.d. no.4 dept of shalakya thantra
🇮🇳Jamnagar, GUJARAT, India
O.p.d. no.4 dept of shalakya thantra🇮🇳Jamnagar, GUJARAT, IndiaProfMANJUSHA RAJAGOPALAPrincipal investigator9428400759bhatrajma2008@gmail.com