Sambhavna Medical Research Report

As highlighted in the Deed of the Sambhavna Trust, "The main object of the Trust is the welfare of the survivors of the Bhopal Gas Disaster through medical care, research, health education and information dissemination."

In fulfilment of its primary objective the Sambhavna Trust has been actively engaged in epidemiological and clinical research for the benefit of the gas victims and those exposed to contaminated ground water. The unprecedented magnitude and nature of toxic exposure, unexpected long term consequences and the lack of knowledge on appropriate therapeutic interventions make medical research in Bhopal imperative both for generating knowledge and for developing treatment methodologies. Despite the involvement of ICMR in 24 medical research projects for 10 years, there are vast knowledge gaps that require to be filled for a better understanding of the consequences, their management and for possible precautionary measures to be taken to minimize some of the long term health problems. Prior to the disaster there was only one research paper on the health impact of Methyl Iso Cyanate (MIC) exposure published in a peer reviewed international journal and it is rather unfortunate that there is still a paucity of such publications. Accessibility to findings of medical research continues to remain an issue of concern and due to lack of coordination between medical research and medical treatment the benefits of medical research have not reached the survivors with chronic illnesses. Despite financial and other resource constraints, Sambhavna Trust has carried out epidemiological and clinical studies following ethical norms and published some of them in international peer reviewed journals. The clinic run by the Trust has the space, trained scientific personnel, experience of carrying research in community as well as in the clinic and access to expertise and institutions.

Research at Sambhavna

In accordance with its Deed, the Sambhavna Trust has invested significant part of its resources into medical research likely to contribute towards "welfare of the survivors of the Bhopal Gas Disaster." The epidemiological and clinical research studies carried out at Sambhavna, as well as the ongoing research projects are broadly directed towards identifying long term, including trans-generational, health impacts of toxic exposure and assessing therapeutic efficacy of safer medical interventions. A list of research carried out till date is presented in Table 1. More recently with greater emphasis being paid to other aspects of scientific research as well as appointment of staff trained in microbiology, research areas of Sambhavna have been expanded to include microbiological research as well as research towards improvement of quality of medicines and environmental safety as is apparent from the summary of ongoing research projects presented in Table 2.

A total of six research activities have been conducted at Sambhavana trust and another eight research activities are ongoing. From these research activities, three articles have been published in indexed international journals and another four articles are in developmental stage.

Table 1 : Research Carried out by Sambhavna Trust

S No.	Title	Year	Population	Parameters	Finding	Outcome
1.	Effects of Yoga practices for respiratory disorders related to the Union Carbide Gas Disaster in 1984	1999	30 persons with respiratory disorders following gas exposure	Spirometry values. Pulse & Respiratory rates.	Yoga can lead to sustained improvement in lung functions of exposed persons with chronic respiratory problems.	Yoga instructors trained by Sambhavna Trust are providing care in two government hospitals
2.	Effect of parental exposure on children.	2001	141 children of exposed and unexposed parents	Anthropomorphic values.	Male children of exposed parents are thinner, lighter and have smaller cranial circumference compared to male children of unexposed parents.	Publication in Journal of the American Medical Association
3.	Long term follow up of persons exposed to toxic gas in-utero.	2006	141 children of exposed and unexposed       parents	Anthropomorphic values. Tanner stage.	Early stunting among male children of exposed parents is followed by a catch-up growth.	Publication in Journal of the Federation of American Societies for Experimental Biology
4.	Anemia prevalence in communities exposed and unexposed to contaminated ground water.	2007	300 adults exposed and 303 adults unexposed to contaminated ground water.	Haemoglobin levels.	Average Hb concentration of men exposed to contaminated groundwater was shown to be almost 1g/dL lower than that of men with access to clean water.	Follow up study required with appropriate sample size.
5.	Comparative efficacy of  Yoga therapy in treatment of Dysmenorrhoea of women exposed to contaminated ground water.	2008	60 women with Dysmenorrhoea	Menstrual pattern. Severity of pain	Yoga was found to be more effective than pain killers.	Yoga therapy included in protocol for treatment of Dysmenorrhoea.
6.	An epidemiological cross-sectional study of the effects of exposure to toxic gases and contaminated water on the Bhopal population.	2010	110, 000 persons in four exposure categories	1. Physical Growth and Mental and Social development milestones for 0 to 5 year old children, 2. Mid arm circumference, cranial circumference, leg length, sitting height, standing height and weight of 2 to 15 years   old children, 3. Mortalities between January 1, 2006 till survey date for all four populations. 4. Mortalities between December 3, 1984 and December 31,1989 for gas exposed population, 5. Reproductive history of all women, 6. Diagnosed Cancers, 7. Diagnosed Tuberculosis, 8. Diagnosed Paralysis and 9. Congenital abnormalities	Preliminary findings indicate that in comparison to unexposed families, gas and contaminated ground water exposed families have significantly larger number of people with TB, paralysis and cancers. Lung, abdominal, throat and oral cancers are significantly higher in gas exposed and gas plus contaminated ground water exposed group. Gas exposed women were found to have suffered significantly larger number of abortions in comparison to unexposed women. Compared to an unexposed population, significantly larger number of children born to gas exposed and contaminated ground water exposed parents had birth defects.	To be sent for publication after final data analysis is over.

Table 2: Summary of Ongoing Research Work in Sambhavna Trust Clinic in May 2018

S No.	Title	Objective	Methodology	Participants	Current Status	Completion  date	Follow up
1.	Comparison of status of health and healthcare of gas affected people with respect to unexposed.	To identify priorities of and improvements required in health care of the gas affected population.	Administration of a field tested questionnaire on a sub sample of the cohort for gas exposed and unexposed individuals.	Tasneem Zaidi, Santosh Kshatriya, Farhat Jahan, Hariom Vishwakarma, Shailendra Chourasia	Data collection over. Analysis of data is ongoing.	May 2018	Report to be forwarded to all agencies involved in health care of gas victims. Hindi report to be distributed among the study population.
2.	Assessment of effectiveness of Ayurvedic treatment in Autoimmune disorders.	Standardize Ayurvedic interventions for Rheumatoid arthritis and Psoarisis	Assessment of effectiveness through follow up questions and investigations pre and post treatment.	Dr. Mrityunjay Mali	Data collection over.	May 2018	Findings to be published in Ayurveda journal.
3.	Establishment of community based system for surveillance of births and deaths.	To establish a self-sustaining system of birth and death surveillance that is under the control of the local population.	Bring together interested members of a community and provide information, training and standard formats for recording of information.	Tasneem Zaidi, Santosh Kshatriya, Farhat  Jahan, Hariom Vishwakarma, Shailendra Chourasia	Focused group discussion among interested members started in two communities.	Pilot phase to be completed by December 2018.	Expanding area of work and periodic monitoring of the work of community based groups.
4.	Development of herbal preservatives for water based herbal  preparations.	To develop safer herbal alternatives to potentially toxic synthetic preservatives such as Sodium benzoate.	Periodic microbiological examination of Areetha (Sapindas Mukorossi) solution following addition of different extracts of Lantana camara.	Vishwamohan Dwivedi, Prachi Gupta	Effects of different extracts of Lantana camara on Areetha aqueous solution is being studied for presence of fungi at periodic intervals.	December 2018	Will apply for patent on herbal preservative. Start routine addition in Areetha solution produced at the Clinic. Share technology with Sambhavna Enterprises.
5.	Use of microbes captured from forest for increasing productivity of medicinal plants.	To improve soil quality and plant productivity.	Microbes harvested from nearby forests are grown and sprayed on soil. Conditions created for survival and growth of microbes in soil. Productivity is compared with those on untreated matched soil.	Manmohan Yadav, Ratna Soni, Mukesh Kushwaha, Prachi Gupta	Microbe population increased through adding jaggery. Sprayed on test patch. Plant lengths and girths measured. Data collection ongoing.	December 2018	In case of positive outcome, a booklet describing the work of harvesting microorganisms and using them for increasing productivity in organic farming will be produced and distributed.
6.	Development of herbal mosquito repellants.	Development of safer alternatives to synthetic mosquito repellents.	Hand roll and dry dough prepared with powdered mixture of Van Tulsi (Ocimum americanum), Neem (Azadirchta Indica) and Vasa (Adhatoda vasica) and a binder.	Chandrakanta, Nandkishore, Vishwamohan	Production and testing of incense sticks is ongoing. Developing machinery for mass production of incense sticks.	March 2019	Large scale production for distribution outside the clinic.
7.	Assessment of effectiveness of herbal alternatives to antibiotics in non-healing wounds.	To standardize herbal interventions against resistant microbes.	Monitor condition of wound treated with herbs and corroborate with culture/ sensitivity of resistant organism with regard to herb extract.	Dr.  Mrityunjay Mali, Ratna Soni, Prachi Gupta	Herbs to be used have been identified. Preparations made to recruit willing subjects.	December 2019	Development of treatment protocol for non-healing wounds. Publication of findings in research journal.
8.	Standardizing herbal alternatives to Fluoconazole for treatment of Fluoconazole resistant candida albicans.	To standardize herbal interventions against resistant fungi.	Monitor condition with treatment with herbs and corroborate with culture/ sensitivity of resistant fungi with regard to herb extract.	Dr. Satiwan Mordia, Dr. Usha Arya, Dr. Mrityunjay Mali, Prachi Gupta	Herbs to be used have been identified. Preparations made to recruit willing subjects.	December 2019	Development of treatment protocol for Fluoconazole resistant candida albicans. Publication of findings in research journal.

Research Ethics Committee

Much attention is paid to ethical aspects of medical research at Sambhavna. No information is collected or test carried out on any individual without her / his formal and informed consent. In accordance of the ICMR Guidelines, Sambhavna's 7-member Research Ethics Committee consists of two medical professionals, a lawyer, two social workers and a representative from the community.

Funding of Research at the Sambhavna Trust Clinic

Medical research carried out at the Sambhavna Trust Clinic has largely been funded by small donations from several thousand individual donors sympathetic to the plight of the survivors. Since its inception, the Sambhavna Trust has received a total of Rs. 23, 80, 138 as institutional grants from the Canadian Institute of Health Research and the Memorial University, Canada. While earlier our application for funding an epidemiological study was rejected by the Indian Council of Medical Research, more recently in January 2017 our application for grants from ICMR for a clinical research in Ayurveda titled "Ayurvedic virechana therapy as a means to detoxify persons in Bhopal with history of chronic exposure to chemicals and heavy metals and documentation of consequent changes in their health status" .has been approved subject to our registration with the DSIR as a SIRO.

Beneficiaries of Research by the Sambhavna Trust

The primary beneficiaries of clinical research carried out by the Sambhavna Trust are the 34, 303 patients registered till date for long term care with the Sambhavna Trust Clinic. Clinical research in to therapeutic efficacy of interventions in Ayurveda or Yoga have gone a long way in improving quality of care as well as significantly reduced unnecessary load of synthetic medicines. Upwards of 10 thousand families exposed to bio-accumulative toxins in the ground water in the vicinity of the abandoned factory could potentially benefit from the findings of the proposed study of Ayurvediuc detoxification. Results of the large scale epidemiological study involving 9 parameters is likely to have significant value for over half million survivors of the gas disaster as well as over 50 thousand residents of communities known to be affected by groundwater contamination.

Publication of Research

Following papers based on research work carried out by Sambhavna staff and others are appended in their entirety.

1. Catch-up growth in males affected by the Union Carbide disaster of 1984 in Bhopal, India

Daya R Varma, Ritesh Pal, Diana Katgara, Satinath Sarangi, Tasneem Zaidi, Steven Holleran, Rajashekhar Ramakrishnan and Shree Mulay

Federation of American Societies for Experimental Biology

Volume 22, Issue 1 Supplement 01 Mar 2008

2. Effects of exposure of parents to toxic gases in Bhopal on the offspring

S. Sarangi Mtech, T. Zaidi, R.K. Pal, D. Katgara, V.G. Gadag, S. Mulay, D.R. Varma

American Journal of Industrial Medicine

Vol. 53, Issue 8, August 2010, pp. 836 - 841

3. Methyl Isocyanate Exposure and Growth Patterns of Adolescents in Bhopal.

Nishant Ranjan, Satinath Sarangi, V T Padmanabhan, Steve Holleran, Rajshekhar Ramakrishnan, Daya R Varma

Journal of American Medical Association

Vol. 290, No. 14, October 8, 2013 pp 1856-1857

Annexures

Catch-up growth in males affected by the Union Carbide disaster of 1984 in Bhopal, India

Effects of Exposure of Parents to Toxic Gases in Bhopal on the Offspring