|Year : 2017 | Volume
| Issue : 1 | Page : 33-38
Clinical study on primary open-angle glaucoma with Ashchyotana, Tarpana and oral medication
Shweta Agrawal, Manjusha Rajagopala
Department of Shalakyatantra, IPGT & RA, GAU, Jamnagar, Gujarat, India
|Date of Web Publication||20-Apr-2018|
Dr. Shweta Agrawal
Room No 202, PG Ladies Hostel, IPGT and RA, GAU, Jamnagar - 361 008, Gujarat
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Glaucoma is the second leading cause of irreversible blindness worldwide and third leading cause in India. The disease progresses even intraocular pressure (IOP) is well under control; hence, now modern medicine is looking for strategies that are neuroprotective in glaucomatous optic neuropathy (GON) management. Aim: This study aimed to propound the concept of Chakshushya Rasayana and diuretic therapies and also evaluate the neuroprotective and IOP-lowering effects of Ayurvedic line of management in primary open-angle glaucoma (POAG). Materials and Methods: In this randomized parallel-group trial, patients having POAG were randomized with equal probability to one of the two treatment groups. Participants were assessed on the basis of subjective parameters such as blurred vision, frequent changes of presbyopic glasses (FCPG), delayed dark adaptation (DDA), visual field defect (VFD) and headache; objective parameters such as best-corrected visual acuity (BCVA), IOP and optic nerve head changes and perimetry findings such as mean deviation (MD) and Glaucoma Hemifield Test. In Group A, after Koshtha Shodhana and Nasya, Tarpana and Ashchyotana with Shigru Pallava Arka were done locally and Punarnavashtaka Kwatha and Gokshuradi Guggulu were given internally for 52 days along with modern antiglaucoma eye drop and in Group B, patients already taking antiglaucoma eye drop were kept under observation for 2 months. Results: Patients in Group A showed better results in blurred vision, FCPG, DDA, VFD, headache, BCVA, IOP and MD. Patients in Group B showed better results in blurred vision and FCPG. A comparison of both groups showed significant results in blurred vision, DDA, VFD, BCVA, IOP and MD. Conclusion: The clinical study concludes that Ayurvedic treatment protocol along with antiglaucoma eye drop in Group A patients was found to be more effective in reducing the IOP and controlling the progression of GON along with modern anti-glaucoma eye drop. Early diagnosis and proper management can prevent, arrest, or delay progression of POAG.
Keywords: Gokshuradi Guggulu, primary open-angle glaucoma, Punarnavashtaka Kwatha, Shigru Pallava Arka
|How to cite this article:|
Agrawal S, Rajagopala M. Clinical study on primary open-angle glaucoma with Ashchyotana, Tarpana and oral medication. AYU 2017;38:33-8
| Introduction|| |
Glaucoma is the second leading cause of irreversible blindness worldwide and third leading cause in India. It is widely termed as “sneak thief of sight” and “silent killer of vision” because of its asymptomatic progression. Globally, primary open-angle glaucoma (POAG) affects more than angle-closure glaucoma (ACG) with a ratio of 3:1. Glaucoma was estimated to affect 60.5 million individuals worldwide by the year 2010. In India, an estimated approximately 11.2 million people aged 40 years will have glaucoma and among them 6.48 million individuals are affected with POAG. According to the NPCB-WHO survey (1986–1989), glaucoma accounts for 5.80% of total blindness in India.
POAG is a multifactorial disease which is affected by multiple factors such as mechanical, vascular and cellular factors; hence, the treatment should also be multilane which includes diuretic for lowering the intraocular pressure (IOP), Rasayana which delays the senile changes and Chakshushya which helps protect the vision, etc. Previous research works have been done on Punarnavashtaka Kwatha and Gokshura Choorna individually at two centers to control the IOP.
Tarpana and Ashchyotana are powerful ocular administration methods used in Ayurveda for effective topical delivery and desired therapeutic action of drug. Shigru Pallava Arka for Tarpana and Ashchyotana (eye drops) are being used by ophthalmic practitioners on glaucoma patients and they report good results but relevant scientific data are not available.
Hence, the study was planned to evaluate the efficacy of Ashchyotana and Tarpana with Shigru Pallava Arka, oral Chakshushya and diuretic medication with Punarnavashtaka Kwatha and Gokshuradi Guggulu in the management of POAG along with modern antiglaucoma eye drop.
| Materials and Methods|| |
A total of 30 patients, from the Department of Shalakya Tantra, Institute for Postgraduate Teaching and Research in Ayurveda (IPGT and RA), Jamnagar, Gujarat, were registered in this randomized parallel-group clinical trial. A prior written informed consent was taken from each and every patient. The clinical study was started after getting clearance from the institutional ethics committee (No. PGT/7/-A/Ethics/2014-15/1538 dated 2/9/14) and the study was also registered under the Clinical Trials Registry-India (CTRI/2016/02/006582).
Patients aged 30–70 years diagnosed with POAG having IOP <21 mmHg (normotensive glaucoma) or IOP >21 mmHg and visual acuity >6/60 with clear media of male and female both sexes were included in the study.
Patients with all types of primary ACG, cataract, secondary and developmental glaucoma including exfoliative glaucoma, pigmentary glaucoma, trauma-induced inflammatory glaucoma, end-stage (advanced) glaucomatous optic neuropathy or ophthalmic artery and visual acuity <6/60 were excluded from the study.
Grouping and Posology
A total of 30 participants were registered in this randomized parallel-group clinical trial. All the patients were randomly assigned into two groups, Group A and Group B (n = 15 each), by adopting lottery method for randomization.
Group A (trial group)
First, Erandabhrishta Haritaki 5–10 g HS was given for Koshtha Shodhana for 3 days.
After that, Nasya Karma with Anu Taila was carried out for 7 days; after Nasya, 7 days gap was given. Then, Tarpana with Shigru Pallava Arka was done for 7 days in 3 courses with an interval of 7 days.
Punarnavashtak Kwatha, Gokshuradi Guggulu orally and Ashchyotana with Shigru Pallava Arka were started from the 1st day of Nasya Karma and continued up to the completion of therapy. With this, the additional management was adopted, which included brimonidine (0.2%) and timolol (0.5%) topical antiglaucoma (IOP lowering) treatment.
Group B (control group)
In this group, patients already taking brimonidine 0.2% and timolol 0.5% topical antiglaucoma (IOP lowering) treatment were kept under observation for 2 months as a control group.
Total duration of treatment was: 52 days
Follow up: 1 month for both groups.
Raw drugs were collected and formulation prepared in the Pharmacy, IPGT and RA, Gujarat Ayurveda University (GAU), Jamnagar. Shigru leaves for Ashchyotana and Tarpana were collected from the premises of the institute campus and Arka was prepared in the Rasa Shastra Department, IPGT and RA, GAU, Jamnagar. The details of Punarnavashtaka Kwatha and Gokshuradi Guggulu are summarized in [Table 1] and [Table 2].
|Table 2: Ingredients of Gokshuradi Guggulu (Sharangdhara Samhita Madhyamkhanda)|
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All these drugs were identified and authenticated in the Pharmacognosy Laboratory, IPGT and RA, Gujarat Ayurved University, Jamnagar.
Criteria for assessment
- Subjective parameters such as blurred vision, delayed dark adaptation (DDA), frequent changes in presbyopic glasses, visual field defect (VFD) and headache were assessed with the help of grading in clinical research proforma
- Objective parameters such as visual acuity using Snellen chart, IOP using Schiotz tonometry, direct and indirect ophthalmoscopic examination for optic nerve head (ONH) evaluation, and visual field evaluation by automated perimetry were used to obtain their values.
Wilcoxon matched-pair signed-rank test and paired t-test were used to assess the results for individual groups. Unpaired t-test and Chi-square tests were used for comparison of results between the groups using SigmaStat software (version 3.1). 2005 developed by Jandel Scientific Software.
| Results|| |
Out of total registered patients, 2 participants discontinued the study (i.e., 6.67% discontinued the treatment), 1 in Group A and 1 in Group B and the remaining 28 patients, 14 in Group A and 14 in Group B, completed the treatment.
For the evaluation of results of symptoms within the group, Wilcoxon matched-pair signed-rank test was applied (paired data). In both the groups, there was a statistically significant improvement in blurred vision, frequent changes of presbyopic glasses (FCPG), DDA, VFD and headache in Group A and significant results were observed in blurred vision and FCPG in Group B [Table 3].
|Table 3: Effect of treatment on symptoms of primary open-angle glaucoma (Wilcoxon matched-pairs signed-ranks test)|
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For the evaluation of results for objective parameters within the groups (paired data), paired t-test was used. In Group A, a statistically significant improvement was found in best-corrected visual acuity (BCVA), IOP and mean deviation (MD) [Table 4].
|Table 4: Effect of treatment on objective parameters of primary open-angle glaucoma (paired' test)|
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Comparison of difference of results between Group A and Group B
A statistically significant change was assessed on comparison (unpaired data) of difference between Group A and Group B with Chi-square test on symptoms such as blurred vision, DDA and VFD [Table 5].
|Table 5: Comparison of difference of symptoms between Group A and Group B (Chi-square test)|
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A statistically significant change was assessed on comparison (unpaired data) between Group A and Group B with unpaired t-test on objective parameters such as BCVA, IOP and MD [Table 6].
|Table 6: Comparison of difference of signs between Group A and Group B (unpaired t-test)|
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In Group A, 57.14% patients showed moderate relief, 28.57% showed mild relief, 7.14% showed no relief, 7.14% showed marked relief and no patient was completely cured, i.e., 0%. In Group B, 78.57% patients showed no relief, 14.28% showed mild relief, 7.14% showed moderate relief and no patient showed marked relief and completely cured, i.e., 0% [Table 7].
| Discussion|| |
Out of total registered patients, 2 (6.67%) discontinued the treatment, 1 in Group A and 1 in Group B and the remaining 28 patients, 14 in Group A and 14 in Group B, completed the treatment. One patient had his/her busy working schedule so he/she was having the treatment regularly and another patient was transferred from Jamnagar and hence discontinued the study.
Maximum numbers of patients, i.e., 40%, were in the age group of 51–60 years. As the age advances, risk factors such as DM and HTN increases along with the occurrence of neurodegenerative disorders which may trigger the glaucoma pathogenesis.,, About 56.67% patients were males. Maximum numbers of patients, i.e., 33.33%, were homemakers. Almost 84.61% of 13 female patients of both groups were in menopausal stage. Recent researches have shown that menopause, especially early menopause, is associated with high-risk POAG. Patients with a negative family history of POAG were 66.67% and with a positive family history of POAG were 33.33%. Out of total registered patients, 53.33% patients were under medical management for glaucoma.
Findings of both the groups suggests that selected drugs are effective, but better results were observed in Group A where both the drugs were given to the participants. This can be because of administration of local IOP-reducing eye drop alone is not sufficient to stop the progression of POAG. Hence, Chakshushya, Rasayana, diuretic and neuroprotection strategy along with IOP-lowering effect of Ayurvedic management, is important to stop the progression of primary open-angle glaucomatous optic atrophy.
Punarnavashtaka Kwatha contains drugs, namely Punarnava, Nimba, Patola, Sunthi, Kutaki, Guduchi, Daruharidra and Haritaki; all drugs have Mootrala, Shothahara, Rasayana, and immunomodulatory effect.
Gokshuradi Guggulu contains nine drugs which are Gokshura, Guggulu, Triphala, Trikatu and Musta. Triphala is a well-known Chakshushya and Rasayana drug and among them. Amalaki is rich in antioxidant vitamins.Trikatu has Ushna, and Teeksna Guna and Ushna Virya act as Srotoshodhaka and Amapachaka. Musta has anti-inflammatory and antioxidant activity. It has superoxide anion scavenging, hydroxyl radical scavenging, nitric oxide scavenging, metal-chelating activity and lipid peroxidation inhibition activity.Gokshura is Srotovishodhaka, immunostimulant, Mootrala (diuretic), and Shothahara. Guggulu is Shothahara, Vednasthapana drug; all these drugs through its their properties are useful to relieve the signs and symptoms of POAG.
Multi centric studies with larger sample size on the same drugs should be carried out to bring authenticity to our science. Photo-documented studies are required to demonstrate the improvement in signs. Higher investigation for evaluation of ONH and retinal nerve fiber layer analysis should be done, as optical coherence tomography, pachymetry etc.
| Conclusion|| |
Group A (trial group) patients showed better results in blurred vision, FCPG, DDA, VFD, headache, BCVA, IOP and MD. Group B (control group) patients showed better results in blurred vision and FCPG. None of the groups had a significant effect on GHD and laboratory investigations. No changes were found in ONH analysis in both groups.
A comparison of both groups showed significant results in blurred vision, DDA, VFD, BCVA, IOP, and MD.
The clinical study establishes that Ayurvedic treatment protocol along with antiglaucoma eye drop in Group A patients was found to be more effective. The test drugs can reduce the IOP and control the progression of glaucomatous optic atrophy along with modern antiglaucoma eye drop. An early diagnosis and proper management on Doshika lines can prevent, arrest, or delay the progression of POAG.
Limitations of study
- Due to time constraints in postgraduation, it was not possible to give a long time for the study
- Due to time constraints, it was not possible to observe the changes on nerve fiber layer and ONH
- Fundus photographs were not included in this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]