The frame of the present research work entitled Effect of Ayurvedic Treatment protocol in the
management of Madhumehajanya Timira w.s.r. to Diabetic
Retinopathy-A Clinical Study has
been disposed into following sections:
1. Introduction
2. Conceptual
study-Ayurvedic & Modern review
3. Drug
review- Pharmacognostical &Analytical Study
4. Procedure
review
5. Clinical
study
6. Discussion
7. Summary
and 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 therapy
after reviewing the previous research works done has been explained thoroughly.
The plan of study with the selected aims and objectives was also given in brief
in this portion. Hypothesis regarding selection of procedures was made upon the
facts that in Madhumeha, there is Rakta vitiation due to Kleda
and Kapha Vargiya Dravyas causing damage to Rasayanis. Later
there will be derangement of Kapha causing Pitta Dushti
and further leads to a condition similar to Raktapitta. Based upon this
hypothesis Koshtashodhana was adopted. Takradhara which checks
bleeding, acts on relieving stress and nourishes the Shira Marma was
adopted along with Nasya which is having sense organ stimulant, Srotoshodhaka
and Raktapittahara properties. Rasayana Yoga was consisting
of all Pramehahara and Chakshushya drugs and was selected on the
basis of hypothesis that it affects both Madhumehameha as well as
Madhumehajanya Timira.
Aims
and objectives
1.
To
understand Madhumehajanya Timira in
the light of Diabetic Retinopathy – various ocular complications of Diabetes
mellitus.
2.
To
evaluate the clinical efficacy of the adopted treatment approach in Diabetic
Retinopathy
Hypothesis
Null Hypothesis (H0)
The adopted
Ayurvedic treatment is not effective in managing Diabetic Retinopathy.
Alternative Hypothesis (H1)
The adopted
Ayurvedic treatment is effective in managing Diabetic Retinopathy.
2) Conceptual
Study:
a) Ayurvedic
review
Madhumehajanya
Timira is a Drishtigata Roga. The term Drishti has
been used both functionally and structurally in our classics. After a
comprehensive review regarding this term, it has been concluded that eyeball as
a whole along with structures directly involved in visual process starting with
tear film, central cornea, lens, retina as a whole and optic tract can be taken
as Drishti with selectivity as per
contexts. In Prameha Pidika, Rasayani Daurbalya concept has come which
occurs due to Kleda and Kapha Bahulya as well as due to Apana and
Vyana Vayu Dushti in the body due to improper/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 fundus
findings later and visual symptoms still later came into consideration while
reviewing the literature.
On comparing the etiological factors a great
similarity between etiological factors of Prameha as well as Netra Rogas
were found. Moreover medieval
period book, Netraprakashika has
a direct reference of Netra Rogas due to Prameha. By taking all
these concepts the study was planned. The modern review of the disease was
taken from different text books, peer review journals and internet. The
pathogenesis involved in is Rasayani Daurbalya (vascular damage
consisting endothelial cell damage, pericyte loss etc.) was analysed in both Ayurvedic
and Modern perspectives.
b) Modern Review
As the major structure
evident to be involved in Diabetic retinopathy is Retina, due importance has
been given to retina and its anatomy has been dealt with in detail. In disease
review, detailed description regarding etiology, pathogenesis, classification
and 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/ reason
behind the selection of formulations.
Under Drug Review,
Pharmacognostical as well as Analytical study of the drugs were given in detail
with their main physico- chemical parameters.
4) Procedure Review:
Procedure review introduces the detailed description
of selected procedures i.e Koshtashodhana Karma, Shirashodhana, Takradhara, Marsa
and Pratimarsha Nasya for the present clinical study.
5) Clinical Study:
Clinical study section deals with the need and plan
of study in detail, aims and objectives, material and methods, criteria for
selection of patients in the study and exclusion criteria, Grouping, treatment
schedule, assessment criteria and observations in tabular form along with the
statistical analysis of results obtained.
1. The
study was approved by Institutional ethics committee letter no. PGT/7
A/Ethics/2015-16/2625 dated 11/12/15.
2. The
Clinical trial was registered under CTRI with CTRI No. CTRI/2016/04/006803
registered on 07/04/2016.
A
Clinical Research Proforma was designed consisting of examination of the
patient, various investigations etc. Based on the assessment criteria and
observations, the effects and results of the therapy were assessed. The
patients were selected by SIMPLE RANDOM SAMPLING METHOD & were divided into
2 groups:
Group
A: (Trial Group) – 70 patients
Group
B :( Control Group) – 30 patients
The study was conducted in black box design.
Inclusion
Criteria
Ø
Patients
willing for the treatment.
Ø
Patients
of 30-70 years having Type 2(Non insulin dependent) diabetes with or without
visual disturbances, but with detectable ophthalmoscopic features of DR.
Ø
Patient
of Type 2(Non insulin dependent) diabetes with blood sugar level, FBS- 126 to
220 mg/dl or PPBS-180 to 300 mg/dl with ongoing treatment.
Exclusion
Criteria
Ø
Patients
who are extremely debilitating and those who are not able to withstand
treatment procedures.
Ø
Patients
of Type-1 Diabetes or the patients of Type-2 Diabetes taking Insulin.
Ø
High
Risk DR or those requiring emergency intervention.
Ø
Patients
of DR with media opacities like cataract, vitreous degeneration etc. which
interfere with ophthalmoscopical findings.
Ø
Patients
having other ocular pathologies like glaucoma, high myopia etc.
Ø
Hypertensive
Retinopathy and DR associated with pregnancy.
Ø
Patients
whose BCVA is less than 6/60
A total of 100 patients
diagnosed to have diabetic retinopathy with symptoms and/or signs were
selected for the study. 10 patients dropped out were later excluded from the
study. 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 to
the treatment in the following method.
STUDY DESIGN
(GROUPING):
Group A:
(Treatment Group)
Preparatory Stage:
1)
Deepana Pachana with Shivakshara
Pachana Churna/ Chitrakadi Vati/ Amapachana
Vati/ Trikatu Churna 5-10 gms/ 1 tablet with lukewarm water orally twice daily for 5-7 days according to the Koshta
of patients.
2)
Koshta
Shodhana with Eranda
Brishta Hareetaki/ Avipattikara Churna -5-10
gms with lukewarm water orally in morning for 3-5 days according to the Koshta
and Prakriti of
patients.
3)
Shirashodhana
with Anu Taila
– 8-10 drops into each nostril for 7 days.
Treatment phase:
1) Marsha
Nasya with Durvadi Ghrita-8-10 drops into each nostril for 7 days followed
by Pratimarsha Nasya with same. Total three sitting of Marsha Nasya
was done.
2) Takradhara
by Siddha-Takra as medium 30 minutes
daily for 15 days in morning. Total three sitting of Takradhara was done.
3) Oral Medication (Anubhuta Rasayana Yoga) - 3 gm at bed time
with 3gm Madhu and 6 gm Ghrita.
All
the above therapies were continued along with Anti-hyperglycemic treatment as
advised by the treating physician.
Group
B: (Control Group)
Diagnosed cases of DM having DR changes were included
and kept under observation till the whole therapy period. They were continued
with their anti-hyperglycemic and anti-DR treatment, if any.
Duration
of Therapy and Follow up:
The therapy was continued for 90 days.
Follow up study was done for 1 month at 15 days
interval.
The
effect of treatment was assessed on the basis of both subjective criteria and
objective criteria; since the improvements in both patients’ vision and
ophthalmoscopic features are necessary in Diabetic Retinopathy to say if the
existing stage of retinopathy regressed or maintained. Specialized scoring pattern for subjective criteria
was adopted. Whereas for objective assessment of therapy Best Corrected Visual
acuity, Ophthalmoscopy, Fundus photography, Fundus Fluorescein Angiography and Optical
coherence tomography was adopted. Laboratory
investigations - FBS, PPBS, HbA1C, S. Cholesterol, Hb, S.G.O.T, S.G.P.T, Urea, S.Creatinine
and Urine sugar were also taken for assessment.
Results were assessed in terms of percentage relief and
statistical evaluations.
Observations (Demographic data)
Maximum number of
patients was of age group between 61-70years. Majority of the patients were
male i.e. 57(57.00%) and rest patients were female i.e. 43(43.00%). Majority of
patients were Hindus i.e. 94(94.00%) and 06(06.00%) patients were Muslim. Majority
i.e. 98 (98.00 %) patients were married. 38(38.00%) patients were house wives
followed 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 study
100.00% belonged to Jangala Desha. Maximum (91.00%) of patients were
Vegetarian. Maximum i.e. 84.00% patients were having good appetite. Maximum
82.00% patients were having sound sleep. It
was observed that 64.00% were having Mridu Koshta.
Maximum (92.00%) patients were having normal micturition. It was
observed that 11.00% patients were addicted to Tobacco. It was observed that
84.00% 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 day
sleeping. Maximum i.e. 66.00% of patients were taking Madhura Rasa dominant
diet. 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 were
having Madhyama Satva, 93.00% patients were found to have Madhyama Sara,
95.00 % of patients were having Madhyama Samhanana, 95.00% of
patients 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 Madhyama
Vikruti.
Observations on Disease.
All (100.00%) of patients
were having complaints of diminished vision, followed by 18.00 % of patients
having complaints of blurriness of vision. No patients had complaints of
frequent 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 were
having hard exudates. In the study, 96.00% patients had gradual onset of ocular
complaints and 04.00% had sudden onset. In the study 63.00 % were having chronicity
of 0-1 year whereas 30.00 % patients were having chronicity of 2 –5 years. Maximum
number of the patients, i.e.48.00% was having history of Diabetes up to 5
years. 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 in
23.00% and 77.00% had no family history of DM. Also 41.00 % were found
to be hypertensive.
A detailed description of effect of therapy was
given on the basis of subjective criteria, objective parameters and lab
investigations. In brief the comparative results of both the groups can be
explained like this-
a) Comparative Effects in both Groups
On Symptoms- On
symptoms like defective vision and blurred vision, both the groups had
statistically insignificant result.
On Signs-Treatment
on Group A was more effective in reducing dot-blot haemorrhages, superficial
haemorrhages, hard exudates and BCVA.
On Lab Parameters- on
lab investigations like FBS and S. Cholesterol, Group A was better than Group B
whereas on PPBS, Hb, HbA1C and urine sugar both the groups were showing more or
less same results which was statistically insignificant. It could also be
concluded that there was no statistically significant change in SGOT, SGPT,
Urea and S. creatinine in Trial group. Thus there was no change in liver
function and renal function tests in patients of trial group after taking Rasayana yoga.
b) Overall
Effect 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 showed
progression.
- 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 discussion
was done on selection of disease, conceptual part, and selection of procedures
and drug with their probable modes of action, clinical study and effect of
therapy on all the selected patients. Some important discussion on results are-
• Group A (Treatment
Group) was effective in reducing dot blot haemorrhages and superficial
haemorrhages. This can be said that Group A indicates towards improving health
of retinal vasculature in this short duration of treatment with a significant
improvement 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 of
the body vasculature is strengthened. That’s why no fresh haemorrhage was
observed.
• Group A was more effective in lowering FBS and
S.cholesterol showing that integrated approach in DM gives a better FBS and
S.cholesterol control. It is reflecting that treatment by Takradhara,
Pratimarsha Nasya and Rasayana therapy after Koshtashodhana in
group A was helpful in blood sugar and S. cholesterol control along with
its maintenance for a long period.
•
There was no statistically significant
change in SGOT, SGPT, Urea and S. creatinine in Trial group. Thus there was no
change in liver function and renal function tests in patients of trial group
after taking Rasayana Yoga.
Koshtashodhana by
virtue of its Kledaharana, Pitta Shodhana, Rakta Prasadana actions;
Sirasodhana due to its Urdhwasrota Shodhana effect; Durvadi Ghrita
Marsa and Pratimarshanasya by its Rakta Sthambhaka and sense organ
rejuvenating properties, Takradhara due to its Raktha Sthambhaka, Kledaharana,
Sophaharana and mental relaxant effect and all drugs used in Rasayana
yoga by their Chakshushya and Pramehahara properties have
their role in combating the pathogenesis of Madhumehajanya Timira
DR. Thus by these virtues the holistic Ayurvedic approach is helpful in
giving a complimentary treatment protocol to the DR
patients.
Secondary outcome of the study: All
patients reported betterment in their physical and mental well being
which suggests that Holistic approach is improving the Quality of life and
vision. 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 during the
entire study period and follow up
CONCLUSION
From the present study following conclusions
are drawn:
• Group A (Treatment Group) showed better
results on Dot blot haemorrhages, Superficial haemorrhages, hard Exudates,
BCVA, FBS and S. cholesterol.
•
Both
the groups showed almost similar effects in PPBS, Hb , HbA1C and urine sugar
which was statistically insignificant.
•
There
was no statistically significant change in SGOT, SGPT, Urea and S. creatinine
in Trial group showing the safety of Anubhuta
Rasayana Yoga.
•
There
was no statistically significant change in symptoms like defective vision and
blurred 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 specially
microvasculature in retina i.e Rasayanis, which prevented further
exudations thereby decreasing retinal oedema leading to improved visual status.
Hence the null hypothesis was rejected and alternate hypothesis ie,†The
adopted Ayurvedic treatment is effective in managing Diabetic
Retinopathy†has been proved. |