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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 6
| Issue : 4 | Page : 181-189 |
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An open-label, randomized, exploratory study to evaluate the effect of internal oleation and therapeutic purgation on lipid profile in patients with skin diseases
Deepa Makhija1, VC Deep2, S Krishna Rao3, Aaditya B Shah4, Rajkala Panchakshari Patil5, Sakshi Sharma6, Bharti Gupta6, Bhagwan Sahai Sharma1, Shruti Khanduri1, Rakesh Kumar Rana1, Richa Singhal1, Narayanam Srikanth1
1 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
2 National Ayurveda Research Institute for Panchkarma (NARIP), Cheruthuruthy, Kerala, India
3 Central Ayurveda Research Institute, Bhubaneswar, Odisha, India
4 Regional Ayurveda Research Institute (RARI), Jammu, Jammu and Kashmir, India
5 Department of Panchkarma, Banaras Hindu University, Varanasi, Uttar Pradesh, India
6 Central Ayurveda Research Institute (CARI), New Delhi, India
| Date of Submission | 05-Oct-2021 |
| Date of Acceptance | 17-Nov-2022 |
| Date of Web Publication | 05-Dec-2022 |
Correspondence Address:
Dr. Deepa Makhija
Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_83_21
BACKGROUND: In Ayurveda therapeutic principles, internal oleation (IO) is essential before Virechana (purgation therapy). The IO is mainly done using plain or specific medicated ghee according to the disease condition. Virechana is a primarily utilized therapy for treating skin diseases. This pilot study evaluates and compares the effect of IO by using cow ghee (CG) and Mahatiktaka Ghrita (MTG), followed by Virechana, on lipid profiles in individuals suffering from skin diseases but having normal serum lipid levels. MATERIALS AND METHODS: A total of 60 patients were enrolled in this open-label, randomized, multicenter exploratory study and equally divided into two groups. The Ayurveda interventions for IO in groups I and II were CG and MTG, respectively. In both groups, after the completion of 3 to 7 days of IO, Virechana, by using Avipattikar churna (AVC), was done. The effect of the interventions was assessed after completion of IO, and the next day after Virechana, by laboratory investigations such as lipid profile, liver function (LFT) and renal function tests (RFT). Comparative statistical analysis of observations between the baseline, after oleation, and after Virechana was done using statistical software SPSS Version 15.0. RESULTS: A total of 55 participants (27 in group I and 28 in group II) completed the study. After IO and Virechana, changes were reported in the lipid profile, LFT and RFT. All the observed changes are within the standard normal range of the respective laboratory parameters. CONCLUSIONS: To some extent, the IO with CG, MTG, and Virechana therapy can result in clinical changes in LDL, LFT, and RFT within normal limits. As per the Ayurveda concepts, Sansarjana Karma is a must after Virechana for complete recovery. Therefore, further research on changes in lipid profile after IO and Virechana following Sansarjana Karma is required. Keywords: Cow ghee, lipid profile, Mahatiktaka ghrita, Snehana, Virechana
How to cite this article:
Makhija D, Deep V C, Krishna Rao S, Shah AB, Patil RP, Sharma S, Gupta B, Sharma BS, Khanduri S, Rana RK, Singhal R, Srikanth N. An open-label, randomized, exploratory study to evaluate the effect of internal oleation and therapeutic purgation on lipid profile in patients with skin diseases. J Res Ayurvedic Sci 2022;6:181-9 |
How to cite this URL:
Makhija D, Deep V C, Krishna Rao S, Shah AB, Patil RP, Sharma S, Gupta B, Sharma BS, Khanduri S, Rana RK, Singhal R, Srikanth N. An open-label, randomized, exploratory study to evaluate the effect of internal oleation and therapeutic purgation on lipid profile in patients with skin diseases. J Res Ayurvedic Sci [serial online] 2022 [cited 2023 Mar 25];6:181-9. Available from: http://www.jrasccras.com/text.asp?2022/6/4/181/362655 |
| Introduction | |  |
Panchakarma (Ayurveda pentabio-purification therapy) is a unique treatment modality of Ayurveda for internal purification of the body. Such purification allows the biological system to return to homeostasis and rejuvenate rapidly.[1],[2] Before the actual purification procedure, there is a need to mobilize the Doshas from all body channels, which is achieved through internal oleation [Snehana (IO)]. IO is the major preparatory procedure to be performed before body purification, wherein the patients are gradually given either a lipid (such as ghee) or a lipid-based formulation (Ayurveda-medicated ghee) for three to seven days. As evident from previous studies, approximately 600 to 1200 ml of Sneha is consumed during the process depending upon the patient’s digestive power.[3],[4]
As a considerable amount of lipid is given for IO, it may generate a potential concern amongst the patients regarding the abnormal increase in lipid levels in the body. Ayurveda uses a wide variety of lipid-based formulations to manage various diseases; the difference in the effect of pure ghee and different types of medicated ghee on lipid profile also needs to be studied. As per Ayurveda classics, IO is one of the primary lines of treatment for Kushtha (different types of skin diseases). Therefore, a pilot study was planned to evaluate the effect on lipid profile after IO using cow ghee (CG) and Mahatiktaka Ghrita (MTG) and after Virechana. Previous studies on IO followed by therapeutic purgation and Sansarjana Karma (post-Panchakarma particular dietary regimen) have reported the lipid-lowering effect of the Virechana (purgation).[5],[6],[7]
| Materials and Methods | | |
The study was carried out at two peripheral institutes of the Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India, viz. CARI New Delhi and NARIP, Cheruthuruthy. The study was conducted following the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants. The Institutional Ethical Committee approved the study of both the study sites (F.No.3/1/2014-NRIP/Tech. dated 08/06/2015 and 6–21/2012-ACRI/Tech./IEC dated 27/03/2015). The study was prospectively registered with the Clinical trial registry of India (CTRI/2017/09/009589). Written informed consent was obtained from the eligible patients before the screening.
Trial design: It was an open label, multicentre, prospective, randomized, exploratory study.
Participants
Inclusion criteria
Patients of any gender between 18–40 years suffering from chronic skin disorders (like eczema, psoriasis, and acne vulgaris) in which IO and therapeutic purgation are indicated and having lipid parameters within normal limits were included in the study.
Exclusion criteria
Patients suffering from peptic ulcer, hypertension, diabetes mellitus, hyperlipidemia, concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > two times the standard upper limit) or renal disorders (defined as S. Creatinine>1.2mg/dl), pulmonary dysfunction (bronchial asthma and/or Chronic Obstructive Pulmonary Disease [COPD]), hypothyroidism, malignancy or any other condition that may jeopardize the study; patients on prolonged (> 6 weeks) medication with corticosteroids, diuretics, anti-dyslipidemia drugs, etc. or any other drugs that may influence the outcome of the study; pregnant/lactating woman and patients who are currently participating in any other clinical trial were also excluded from the study.
Interventions
Trial drugs were procured from GMP-certified company, “Oushadhi” - The Pharmaceutical Corporation Kerala Ltd, Kuttanellur, Thrissur, and National Ayurveda Research Institute For Panchkarma (NARIP), Cheruthuruthy. Panchakola Churna, MTG, and AVC were procured from Oushadhi, and CG from NARIP, Cheruthuruthy.
As per Ayurveda principles, the dose of Snehapana (IO) depends on individual digestive capacity. Hence, a dose range was fixed for IO in the protocol. Panchakola Churna (3 gm, twice daily, for three days) was administered before beginning the IO. The participants were advised to take lukewarm water whenever they felt thirsty throughout the day. After that, IO was started with a dose of 30 -50 ml in the early morning, and the quantity of IO was increased in the range of 30 to 60 ml per day, depending upon the time required to digest the previous day’s Sneha (dose of oleation medicine). After completing the entire course of IO, i.e., after 3–7 days, body massage with Tila Taila (sesame oil) was done for 30 minutes, followed by steam fomentation with the decoction of Dashamoola for 20 minutes for three days. After the Snehana procedure, a gap of three days was kept before administering Virechana drugs to avoid Kaphotklesha (~nausea and reflux of mucus). On the fourth day, Virechana was performed by oral administration of AVC. The number of loose motions were counted till the appearance of characteristics of proper therapeutic purgation, like the cleansing of the body channels, clarity of senses, malaise, stopping of purgation on its own, and feelings of lightness in the body appeared. After purgation, the participant was advised to take a light meal in the evening and adhere strictly to the prescribed diet and lifestyle regimen as per the Sansarjan Krama for 3–7 days depending upon the type of Shuddhi (purification). Sansarjan Krama for 3/5/7 days was advised for Avara (least), Madhyama (moderate), and Pravara (excellent) Shuddhi, respectively. The intervention detail is depicted in [Table 1], and the study procedure details are depicted in [Figure 1] and [Figure 2].
Dietary and other restriction during IO period[12]
Dietary instructions include taking food that should be predominantly in liquid form, warm, non-secretary, not too unctuous, not mixed with wide varieties of substances, and in appropriate quantity. The patients were also advised to avoid suppressing their body’s natural urges, use hot water for all routine needs, maintain celibacy, get a decent night’s sleep, avoid exercise, anger, grief, sun exposure, and strong winds; avoid sleeping during the day; avoid smoking, and should stay away from dust. Light rice gruel was given when the patient felt hungry. Luke-warm water was recommended for drinking to facilitate Sneha’s proper digestion.
Outcome measures
The primary outcome was to assess the change in serum lipid profile from baseline to the end of IO and after therapeutic purgation. The secondary outcome was to compare the change in serum lipid profile in two study groups after IO and purgation.
The primary and secondary outcomes were assessed at baseline, at the end of internal oleation, and the next day of Virechna. Laboratory investigations include serum lipid profile, Liver Function Tests, Kidney Function Tests, Total Leucocyte count (TLC), Differential Leucocyte count (DLC), Erythrocyte Sedimentation Rate (ESR), Hemoglobin (Hb)% and fasting and post-prandial blood sugar.
Sample size
The study was planned as an exploratory study; therefore, a sample size of 60 (30 in each group) was considered appropriate.[13] Since the study was executed at two centers, each center was allotted a sample size of 30 (15 in each group). For two centers [30 from each center (Group I-15 and Group II -15)]. As the study was proposed as a pilot study, it was done on a small sample size design.
Randomization and allocation concealment
The participants eligible for enrollment were randomized to either of the study groups in the ratio of 1:1. The computer-generated randomization schedule was prepared by an independent statistician using SPSS version 15.0. The randomization sequence was concealed by the sequentially numbered, opaque, sealed envelope (SNOSE) technique.
Statistical analysis
The descriptive data has been reported as number (frequency). The continuous data on outcome measures and safety parameters have been reported as mean (SD) and was compared using paired t-test. intergroup comparison was done using unpaired t-test. A p <0.05 has been considered significant. The study data was analyzed using SPSS Version 15.0.
| Observations and Results | | |
A total of 63 patients were screened for the study, out of which three were excluded (reason: not meeting inclusion criteria). After the screening, 60 patients were enrolled (30 in each study group). Data of five participants were not included in the final analysis due to deviation from study protocol (n=3) and drop-out due to loss to follow-up (n=2).
There was approximately equal gender-wise distribution of participants in the study. Most participants were literate (89.1%), 56.4% belonged to urban areas, and90.9% had no addiction. Most of the participants (61.8%) were non-vegetarians [Table 2]. | Table 2: Demographic profile and baseline characteristics of study patients (Gr. I =27 & Gr. II =28)
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The effect of IO on lipid profile levels in Groups I and II showed non-significant changes except for a minimal decrease within normal limits in Serum Triglycerides and VLDL in group II. LDL in group I and LDL and HDL in group II increased within normal limits after Virechana [Table 3] and [Table 4]. A non-significant difference between the two groups is observed for all lipid profile parameters after IO [Table 5]. The laboratory parameters for liver and kidney function slightly increased within normal limits after IO and Virechana in both the study groups [Table 6] and [Table 7].  | Table 5: Comparison of effect of treatment on lipid profile between the groups
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 | Table 7: Effect of the treatment on safety parameters in Group II (n=28)
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| Discussion | | |
In the Panchakarma procedures, the IO assists in mobilizing the vitiated Dosha to the gastrointestinal tract, from where they can be eliminated either by therapeutic emesis or purgation. The effectiveness of the Panchakarma is greatly affected by the proper administration of the IO.[14] The procedure of IO is meant for bringing Dosha from the Shakha (~channels where the vitiated Dosha are located) to the Koshtha (~gastrointestinal tract). In the Ayurveda perspective, increasing the digestive capacity can help in the proper assimilation of the lipid used for IO. Therefore, a drug that can improve digestion, such as Panchakola Churna, is administered before the beginning of the IO. The comparison of the effect of CG and MTG as interventions is studied because CG and MTG are most commonly used for IO. AVC, used for Virechana, is a mild laxative with a dose of 3 to 6 gm.[15] Hence, for proper Virechana, the dose needed to be increased, and thus a dose range of 20–30 gm was administered.
The results of the present study revealed changes within normal limits in some of the studied laboratory parameters (lipid profile, LFT, KFT) compared to baseline, after IO, and after Virechana, in both the groups. Studies have been carried out to see the effect of IO on lipid profile and reflect that ingestion of lipids does not cause an pathological increase in lipid profile levels and biochemical parameters.,[16],[17],[18] The observed changes in the present study are also transient and within the standard normal range. The classical text of Ayurveda emphasizes the necessity of strictly following Sansarajana Karma, especially after therapeutic emesis and purgation. The Sansarajana Karma is a dietary regimen that includes low calorie, easily digestible diet taken in small quantity. The Sansarajana Karma is essentially planned for the recovery of the individual’s body from the effect of excess lipid intake as well as to alleviate the exertion caused due to Virechana on the internal organs.[19] From the Ayurveda perspective, it can be interpreted that the Agni (~digestive capacity) of the individual gets diminished after Virechana. The condition can cause an inability to metabolize the remaining Sneha in the Rasa Dhatu (~serum/blood plasma). Sansarajana Karma is recommended to improve the Agni. In the present study, the parameters were studied next day after VirechanaKarma. It may be a reason for the observed changes in the lipid profile and the biochemical parameters.
During purgation, there is an excretion of the large number of watery stools that can transiently disturbs the gut microbiota.[20] Many studies support that gut microbiota is closely related to lipid metabolism disorders.[21],[22],[23],[24],[25] So, easily digestible diets (different types of gruels) are administered post Sodhana in the form of Samsarjana Krama.
A slight decrease within normal limits of triglycerides and VLDL was also observed in group II (Mahatiktak Ghrita) in the present study. Though ghee contains enough saturated fatty acids, but when processed with herbal drugs, it acquires the properties of the drugs and thus may have resulted in a decrease in the value of triglyceride and VLDL in this study. The changes reported in the MTG administered group are considerably more than in CG treated group. However, both groups showed a non-significant difference when compared, indicating a similar cause for the observed changes. In the present study, the Pachana procedure before the administration of ghee, the administration of warm water and dietary regimen during and after oleation can be potential confounders with regards to lipid lowering effect. However, as per the basic principles of Ayurveda for appropriate oleation therapy, to make the patient body ready and to prevent any untoward effect of oleation, the foresaid procedures are also to be administered along with IO.
In this pilot study, the laboratory investigations were carried out on the next day of Virechana (at the initiation of Sansarjana Karma). However, for assessing the effect of Panchakarma procedures on the lipid profile, the investigation parameters should be studied after the completion of the Sansarjana Karma. The findings presented in the current work do not influence the validity nor contradict the results of earlier researches because of the difference in the time of outcome analysis.
| Conclusion | | |
The IO with CG and MTG followed by Virechana may result in slight changes within normal limits in lipid profile when analyzed before completion of Sansarjana Karma. All the observations are within the standard normal range concluding that IO and Virechana do not cause abnormal changes in the lipid profile.
Limitations of the current study
The current work is a exploratory study with limited sample size. Because of the limited sample size, comparative statistical analysis of the effect of variables such as different duration of IO and the extent of Virechana (Pravara, Avara, and Madhyama Shudhi) is not done. The effect of internal oleation on lipid profile was assessed only at the end of internal oleation and purgation. A repeat test of lipid profile at the end of Samsarjan Karma should have to be done to essentially assess the influence of internal oleation on lipid profile. As the whole protocol involves different aspects like Pachana, dietary restrictions and warm water as an adjuvant, there are possible confounders involved in the present study design. Further studies addressing these issues with a statistically significant sample size without harming the basic principles of Ayurveda is warranted.
Acknowledgement
We wish to acknowledge Prof. (Vd.) K. S. Dhiman, Former DG, CCRAS for his valuable directions in implementation of the project. Further, we wish to thanks Director (Institute) of NARIP Cheruthuruthy, Laboratory and Panchkarma staff of the project working at the CARI New Delhi and NARIP Cheruthuruthy for successful implementation of the project.
Financial support and sponsorship
This work was supported by the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]
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