Accomplished

Hypertension

Pilot study on Hypertension
In spring of 1988, 1104 resident Tibetans of above 30 years of age in and around Dharamsala were screened and 285 people were found to be hypertensive. The incidence of hypertension among Tibetan refugees has been shown to be disturbingly high, and at the same time many positive reports in treating hypertension with the use of Tibetan medicine has been credited in bringing the study of this particular illness to the fore. Therefore this study was undertaken by the Clinical Research Dept. of Men-Tsee-Khang in the year 1989 for a period of six months to test the efficacy of traditional Tibetan herbal remedies in treating hypertension. This pilot study was a blind, placebo controlled, quantitative study. The trial was carried at Gangkyi Branch clinic, Dharamsala, for six months on 83 patients who were non randomly allocated in two arms, one arm receiving treatment (12 different kinds of Tibetan medicines) and other arm receiving a Placebo (4 kinds of Tibetan Medicine having neutral potency).They were accessed to blood pressure reading every week. Statistical comparison between control group and experimental group were performed using a Student’s T-test.

There was no significant statistical difference in mean systolic or diastolic pressure between initial values up to any time point within the six months of treatment (p>.1). There were also no significant differences between the initial blood pressure values for the experimental and control groups, and that the control group values also did not change over time. The blood pressure readings of each patient were averaged for a week following the use of each medicine and standard deviation were computed. These data indicate that none of the medicine led to decreased blood pressure in the weeks following its administration, either relative to baseline, to placebo treatment, or to other Tibetan medicines.

Hypertension Survey

The various Men-Tsee-Khang (TMAI) branch clinics have witnessed a significant rise in hypertension cases amongst the Tibetan people within India, which has been attributed to the population’s high dietary intake of calories and fats, their relative sedentary lifestyle, and the underlying stress associated with the trauma of adapting with new environments and family separation. These risk factors are also coupled with a lack of public awareness about hypertension, and poor access to health care systems to address this rising prevalence of hypertension. In this study Tibetan people within the age range of 30-70 were asked to come for blood pressure screening and to participate in the Schedule Standardized Interview, which allowed for the collection of people’s identification details, physical examinations findings, dietary patterns, behavioral factors, physical & mental activity and prior treatment history. The study results found that 46% of the population screened was found to be hypertensive. The associated factors noted in the survey such as male gender, being overweight, a dietary intake of alcohol, non-vegetarian diet and Tibetan butter salted tea, and physical inactivity were shown to play significant and independent roles in the development of hypertension amongst the Tibetan refugees residing in the northern and southern settlements in India. The detail report has been published in Men-Tsee-Khang News Letter, Vol. XX, March -2011.

Hypertension Study
The treatment of hypertension in a traditional Tibetan medicine has been a potential hope in Hypertensive patients that is increasing rapidly as per the reports of various branch clinics of Men-Tsee-Khang, Tibetan Medical and Astrological Institute and the recent Hypertension survey, a hope of fruitful, holistic treatment and a freedom from the clutches of lifetime allopathic medication. This needs to be demonstrated by showing the efficacy and safety of traditional Tibetan medicine or Sowa Rigpa. Therefore, an Open, single centre, non – randomized, comparative study on 150 participants was initiated by Clinical Research department of Men-Tsee- Khang at Dekyiling Branch Clinic, Dehradun on 26th April 2009. The criteria for the eligibility of  participants were of age between 30-70 who were either untreated case or newly diagnosed hypertensive patients with blood pressure of >125/85 mm/Hg  and < 159/99. Four selected medicines of traditional Tibetan medicines along with Dietary control & Lifestyles counseling formed intervention arm, where as Dietary & Lifestyles counseling alone was the control arm of this study. One hundred and fifty patients were allocated into one of the two groups. Seventy participants in the treatment group (Group I) and sixty seven participants in control group (Group II) completed the study. It was found that the percentage reduction in SBP was similar in both the treatment and control arm at both 3 and 6 months. Diastolic blood pressure in both the treatment and control arm showed increase at six months. However, in the treatment group, increase in DBP was significantly less at 6 months as compare to control group (p-value=0.0035). There were no adverse effect and adverse event noted or reported during trial period. The detail report will soon publish in sMen-rTsis Journal, 2012

Diabetes

Diabetes Survey
A descriptive study was done to study the prevalence of Type 2 Diabetes in Tibetan settlements in South India in December 1997. There has been no reported study of DM among the Tibetan population. The sample size consist of 2052 people in the south Tibetan settlement, 980 people in and around Dharamsala and 800 Tibetan people in the Bodhagaya region, totaling to 3821 people with the age range from 30-65 years old participated in this study. We came to learned that 132 participants found out to be diabetic≥ 126 mg/dl in fasting or plasma glucose > 200 mg/dl after intake of 75 gm of glucose. In this study, the crude prevalence rate of DM was 3.4%. DM can be considered to be a significant problem in this migrant Tibetan population. We also came to know of very high incidence of hypertension in the Tibetan population. A note should also be made of a possibly occurrence of cerebral vascular disease. Separate studies on hypertension and stroke are needed to confirm their high prevalence.

Diabetes Study
The Clinical Research Department of Men-Tsee-Khang in collaboration with All India Institute of Medical Sciences (AIIMS), New Delhi, undertook a study to assess the efficacy of Traditional Tibetan medicine in controlling the blood glucose and glycated hemoglobin (GHb) in newly diagnosed or untreated type 2 diabetes from 1997 to 2000. A total number of 200 newly diagnosed or untreated type 2 diabetes patients were recruited from the Bangalore branch clinic in South India and New Delhi branch clinic in North India. The patients were randomized into two groups, the treatment group and the control group. The treatment group was treated with traditional Tibetan medicine along with diet and lifestyle modifications and the control group was treated only with dietary and lifestyle modification. The result showed significant changes in both blood glucose (FBG and PPBG) and HBa1c level in the treatment group. Hence, the preliminary trial has shown a positive effect of the use of Tibetan Medicine in management of diabetes mellitus. The detail report of the study was published in Diabetes Care 24:176-177 in 2001. Visit: care.diabetesjournals.org/content/24/1/176.full

Cancer Study

Cancer is one of the chronic diseases Tibetan Medicine has shown some positive effect depending on the stage of the disease. The need to design a clinical study was felt for a long time and during a meeting on cancer in 1996, it was decided to commence with a baseline study before launching on a clinical study. The objectives of this study was to identify the type of cancer where Tibetan Medicine is the most effective, the stages of cancer, alleviating the symptoms, improving the quality of life and life span, and to specify the particular Tibetan drugs for cancer. The baseline study went through 1998-2001 registering 638 Ca patients from 15 MTK’s branch clinics. The study showed marked improvement in alleviating the symptoms, controlling the disease, improving the quality of life physically and mentally and pro longing the life span.

Chronic Hepatitis B

Chronic Hepatitis B Study-I
A clinical study on Hepatitis B was started from April 2004 to December 2004. It was an Open Randomized Control Single Centre Study. After obtaining patient’s consent, 50 patients were selected following WHO selection criteria. The patients were grouped into two arms with one arm receiving Specific Tibetan Medicine for Hep’ B and another arm receiving Traditional Tibetan Medicine for Hep’ B. The primary objective was to evaluate the efficacy of Tibetan Medicine in treating Chronic Hep’ B patients. The Specific Tibetan Medicine and the Traditional Tibetan Medicine were comparable for LFT and hepatitis B related symptoms. However in spite of randomization, the Specific Tibetan Medicine group i.e., group I have significantly higher LFT value and worse symptoms, indicating poorer LFT control in this study that received the Specific Tibetan Medicine. Both the group of Specific and Traditional Tibetan medicine showed significant improvement in Liver Function Test and HBV related symptoms. However, there is no any case of conversion from 49 patients who completed the six months course of study. The full report has been published in sMan-rTsis Journal of MTK, Vol, IV, Issue 1, August 2007.

Chronic Hepatitis B Study-II
Another comparative study on the evaluation of effectiveness and safety of Tibetan Medicine in treating chronic Hep’B was done at Bylakupee branch clinic of Men-Tsee-Khang for a period of six months in the year 2007. With one group receiving specific Tibetan Medicine and the other group receiving regular traditional Tibetan Medicine were compared for Hepatitis B viral load (HBV DNA), LFT, HBsAg and HBeAg during the course of the study. The data has been documented to be statistically analyzed by a statistician.

Toxicity

Toxicity Study I (Use of Mercury in Tibetan Medicine)
Toxicology study on use of Tsothel (detoxified mercury) in Tibetan medicine for 11 patients was done in the year 2003. It was an open, retrospective controlled pilot study, constituting an initial feasibility stage of a larger, future prospective study in collaboration with Natural Medicine Research Unit, Israel; Delek Hospital, Dharamsala, India; Dept. of Chemistry, University of Liverpool, Liverpool, UK. The study concluded that pre-longed use of detoxified mercury (Tsothel) doesn’t show any sign of toxicity as speculated by western bio-medicine.
The current study, although  performed on only a small cohort of patients tend to support the hypothesis that a prolonged intake of the purified form of mercury, known as Tsothel in Tibetan Medicine is relatively non-toxic. These initial results are of particular interest in view of the growing popularity of Tibetan Medicine in the west; however there is no doubt that further research needs to be performed. The detail report of the study was published in Human & Experimental Toxicology Medical Journal with reference to Human & Experimental Toxicology (2006)25:405-412 and in sMen-rTsis Journal vol. IV, 2007

Cell Line Study 
The purpose of this study was to explore the possible stimulating effects of the Tibetan Medicine called Pokar 10 in two cell types that have been stressed in an impoverished medium over 5 days. This study was carried out in May, 2004 in collaboration with Tissue Culture laboratory at Portland Community College, Portland, Oregon, USA. Both cell types were fibroblasts, fast growing connective tissue cells secreting an extra cellular matrix rich in collagen and other macromolecules. The Tibetan Medicine Pokar 10 is often given for the treatment of joint inflammation/ pain and skin diseases.
The cell submitted to concentrations of Tibetan Medicine were noticed to be growing “extensions” to their cytoplasm material, appearing to reach specifically for the Tibetan compound, grabbing and engulfing bit of it. This movement in the direction of the Tibetan Medicine can be referred to as a positive chemotropic response. Further testing would be required to continue documenting the earlier responses of the fibroblast cells, and also to attempt to understand and explain the physiological mechanisms by which the Tibetan Medicine was able to beneficially affect the culture cell line. The detail report has been published in sMan -rTsis Journal of Men-Tsee-Khang (English), Vol. IV, Issue 1, August, 2007.

Cell Line Study

The purpose of this study was to explore the possible stimulating effects of the Tibetan Medicine called Pokar 10 in two cell types that have been stressed in an impoverished medium over 5 days. This study was carried out in May, 2004 in collaboration with Tissue Culture laboratory at Portland Community College, Portland, Oregon, USA. Both cell types were fibroblasts, fast growing connective tissue cells secreting an extra cellular matrix rich in collagen and other macromolecules. The Tibetan Medicine Pokar 10 is often given for the treatment of joint inflammation/ pain and skin diseases.

The cell submitted to concentrations of Tibetan Medicine were noticed to be growing “extensions” to their cytoplasm material, appearing to reach specifically for the Tibetan compound, grabbing and engulfing bit of it. This movement in the direction of the Tibetan Medicine can be referred to as a positive chemotropic response. Further testing would be required to continue documenting the earlier responses of the fibroblast cells, and also to attempt to understand and explain the physiological mechanisms by which the Tibetan Medicine was able to beneficially affect the culture cell line. The full report has been published in sMan -rTsis Journal of Men Tsee Khang (English), Vol. IV, Issue 1, August, 2007.

Ongoing Studies

1. Pilot study on Peptic Ulcer

2. Pilot study on Gastritis

3. Follow-up clinical Study on Newly Diagnosed Type=II Diabetes

4. Evaluation and Safety of Tsothel in Tibetan Medicine

5. Cancer case study